Allergic Bronchopulmonary Aspergillosis, Blastomycosis, Chronic Pulmonary Aspergillosis, Coccidioidomycosis, Histoplasmosis, Invasive Candidiasis, Invasive Pulmonary Aspergillosis, Mucocutaneous Candidiasis, Other Emerging Fungi, Recurrent Vulvovaginal Candidiasis
Conditions
Brief summary
This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp (SCY-078) in patients ≥ 18 years of age with a documented fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.
Detailed description
This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp in patients ≥ 18 years of age with a documented invasive and/or severe fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment. Patients will be treated with ibrexafungerp for up to 180 days. Treatment beyond 180 days and combination therapy with other antifungal agents may be allowed under special circumstances to be agreed upon by the Investigator and the Sponsor. Subjects must have a proven or probable fungal disease and meet all study criteria to be considered for enrollment. Eligible subjects must also have documented evidence of failure of, intolerance to, or toxicity related to a currently approved SoC antifungal treatment. Subjects will also be considered for enrollment if they have an eligible fungal disease and, in the judgement of the investigator, the subject cannot receive approved oral antifungal options (e.g. susceptibility of the organism or risk for drug-drug interactions) and a continued IV antifungal therapy is not desirable or feasible due to clinical or logistical circumstances. Following a screening visit, there will be up to 15 treatment visits, a follow-up visit and 2 follow-up contacts.
Interventions
Experimental Study Drug
Sponsors
Study design
Intervention model description
Open label, non-comparator, single arm
Eligibility
Inclusion criteria
Key Inclusion Criteria: 1. Must have a documented eligible invasive and/or severe fungal disease that is refractory or intolerant to Standard-of-Care treatment 2. Be able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube 3. Be able to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures. 4. Be able to understand and sign a consent or authorization form which shall permit the use, disclosure and transfer of the subject's personal health information. (e.g., in the U.S. HIPAA Authorization form). 5. Be able to understand and follow all study-related procedures including study drug administration. 6. Agree to use a medically acceptable method of contraception while receiving protocol-assigned product. Key
Exclusion criteria
1. An invasive fungal disease with CNS involvement. 2. Subject has an inappropriately controlled fungal disease source (e.g., persistent catheters that cannot be removed and are likely the source of infection). 3. Subject is hemodynamically unstable, requiring vasopressor medication for blood pressure support. 4. A life expectancy \< 30 days. 5. Subject with abnormal liver test parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT) \>10 x the upper limit of normal (ULN), and/or total bilirubin \> 5 x ULN. 6. Subject is pregnant or lactating. 7. Subject has used an investigational drug within 30 days prior to the baseline visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. | The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by fungal disease. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Describe Ibrexafungerp Plasma Concentrations | Day 2 post-dose, Day 3-5 pre-dose, Dat 7-10 pre-dose. | Ibrexafungerp plasma concentrations measured at specified timepoints prior to and after administration of study drug for participants that received the following dose regimen: Day 1 and 2 loading dose - 750mg BID Day 3 onwards - 750mg QD |
| Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. | The percentage of participants who achieve a Global Response (defined as complete or partial response) as determined by the DRC by enrollment category, at disease specific timepoints. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Participants may have been enrolled for more than 1 enrollment reason. |
| Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. | The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by disease category. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. |
| Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. | The percentage of participants with a Clinical Response as determined by the DRC at disease specific timepoints, by disease category. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms. |
| Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. | The percentage of participants with a Clinical Response as determined by the DRC by disease category and by pathogen isolated, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms. |
| Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. | The percentage of participants with a Clinical Response as determined by the DRC by fungal disease, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms. |
| Time to Death From Any Cause | Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other. | Time to death from any cause in days per Fungal Disease |
| Percentage of Participants With a Mycological Response by Disease Category | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. | The percentage of participants with a Mycological Response as determined by the DRC by disease category, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection. |
| Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. | The percentage of participants with a Mycological Response as determined by the DRC by disease category and by pathogen, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection. |
| Percentage of Participants With a Mycological Response by Fungal Disease | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. | The percentage of participants with a Mycological Response as determined by the DRC by fungal disease, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection. |
| Percentage of Participants With a Mycological Response by Enrollment Category | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. | The percentage of participants with a Mycological Response as determined by the DRC by enrollment category, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection. |
| Percentage of Participants With a Recurrence of Baseline Fungal Disease | 42 days for vulvovaginal candidiasis and 6 weeks after End of Treatment (up to 180 days after treatment start) for all other diseases. | The percentage of participants with a recurrence of their baseline fungal disease as assessed by the DRC at the 25-Day Follow Up (FU) for Vulvovaginal Candidiasis and at the 6-Week FU for all other diseases as assessed by the DRC. Recurrence is defined as having Global Response at end of treatment or test of cure, but re-emergence of the baseline fungal disease during the post treatment follow-up. Re-emergence is required to be with the same species and involving the same site identified at baseline. |
| Percentage of Participants Surviving at Day 30 or Day 42 | Day 30 post-Baseline for Invasive Candidiasis and Day 42 post-Baseline for all other fungal diseases. | Percentage of participants with invasive candidiasis surviving at Day 30 post-Baseline or percentage of participants with other fungal diseases surviving at Day 42 post-Baseline. |
| Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline. | The percentage of participants with a Clinical Response as determined by the DRC by enrollment category, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms. |
Countries
Austria, Germany, Netherlands, Pakistan, South Africa, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ibrexafungerp (SCY-078) Ibrexafungerp (SCY-078), orally administered QD for up to 180 days. | 233 |
| Total | 233 |
Baseline characteristics
| Characteristic | Ibrexafungerp (SCY-078) |
|---|---|
| Age, Continuous | 53.6 years STANDARD_DEVIATION 16.23 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 219 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 16 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 180 Participants |
| Sex: Female, Male Female | 128 Participants |
| Sex: Female, Male Male | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 15 / 233 |
| other Total, other adverse events | 215 / 233 |
| serious Total, serious adverse events | 102 / 233 |
Outcome results
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease.
The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by fungal disease. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Population: Intent to Treat (ITT) Population - all participants who were enrolled in the study and received at least one dose of study drug.~Per Protocol (PP) Population - include all ITT participants who received enough study drug to enable clinical efficacy judgement as determined by the DRC, who have an EOT or TOC (as applicable) assessment and who have no major protocol violations that could impact the assessment of efficacy.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Overall Study (ITT) | Success | 142 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Overall Study (ITT) | Failure | 69 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Overall Study (ITT) | Not Evaluable | 22 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Overall Study (PP) | Success | 131 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Overall Study (PP) | Failure | 59 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Overall Study (PP) | Not Evaluable | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Acute Invasive Candidiasis including Candidemia (ITT) | Success | 40 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Acute Invasive Candidiasis including Candidemia (ITT) | Failure | 13 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Acute Invasive Candidiasis including Candidemia (ITT) | Not Evaluable | 8 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Acute Invasive Candidiasis including Candidemia (PP) | Success | 37 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Acute Invasive Candidiasis including Candidemia (PP) | Failure | 10 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Acute Invasive Candidiasis including Candidemia (PP) | Not Evaluable | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Chronic Invasive Candidiasis (ITT) | Success | 30 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Chronic Invasive Candidiasis (ITT) | Failure | 9 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Chronic Invasive Candidiasis (ITT) | Not Evaluable | 4 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Chronic Invasive Candidiasis (PP) | Success | 25 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Chronic Invasive Candidiasis (PP) | Failure | 7 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Chronic Invasive Candidiasis (PP) | Not Evaluable | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Esophageal Candidiasis (ITT) | Success | 9 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Esophageal Candidiasis (ITT) | Failure | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Esophageal Candidiasis (ITT) | Not Evaluable | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Esophageal Candidiasis (PP) | Success | 9 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Esophageal Candidiasis (PP) | Failure | 4 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Esophageal Candidiasis (PP) | Not Evaluable | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Oropharyngeal Candidiasis (ITT) | Success | 9 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Oropharyngeal Candidiasis (ITT) | Failure | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Oropharyngeal Candidiasis (ITT) | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Oropharyngeal Candidiasis (PP) | Success | 8 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Oropharyngeal Candidiasis (PP) | Failure | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Oropharyngeal Candidiasis (PP) | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Chronic Mucocutaneous Candidiasis (ITT) | Success | 8 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Chronic Mucocutaneous Candidiasis (ITT) | Failure | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Chronic Mucocutaneous Candidiasis (ITT) | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Chronic Mucocutaneous Candidiasis (PP) | Success | 8 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Chronic Mucocutaneous Candidiasis (PP) | Failure | 4 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Chronic Mucocutaneous Candidiasis (PP) | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Vulvovaginal Candidiasis (ITT) | Success | 26 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Vulvovaginal Candidiasis (ITT) | Failure | 4 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Vulvovaginal Candidiasis (ITT) | Not Evaluable | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Vulvovaginal Candidiasis (PP) | Success | 24 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Vulvovaginal Candidiasis (PP) | Failure | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Vulvovaginal Candidiasis (PP) | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Disseminated/Invasive Dimorphic Fungi (ITT) | Success | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Disseminated/Invasive Dimorphic Fungi (ITT) | Failure | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Disseminated/Invasive Dimorphic Fungi (ITT) | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Disseminated/Invasive Dimorphic Fungi (PP) | Success | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Disseminated/Invasive Dimorphic Fungi (PP) | Failure | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Disseminated/Invasive Dimorphic Fungi (PP) | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Chronic Pulmonary Aspergillosis (ITT) | Success | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Chronic Pulmonary Aspergillosis (ITT) | Failure | 6 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Chronic Pulmonary Aspergillosis (ITT) | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Chronic Pulmonary Aspergillosis (PP) | Success | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Chronic Pulmonary Aspergillosis (PP) | Failure | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Chronic Pulmonary Aspergillosis (PP) | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Allergic Bronchopulmonary Aspergillosis (ITT) | Success | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Allergic Bronchopulmonary Aspergillosis (ITT) | Failure | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Allergic Bronchopulmonary Aspergillosis (ITT) | Not Evaluable | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Allergic Bronchopulmonary Aspergillosis (PP) | Success | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Allergic Bronchopulmonary Aspergillosis (PP) | Failure | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Allergic Bronchopulmonary Aspergillosis (PP) | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Invasive Pulmonary Aspergillosis (ITT) | Success | 12 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Invasive Pulmonary Aspergillosis (ITT) | Failure | 14 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Invasive Pulmonary Aspergillosis (ITT) | Not Evaluable | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Invasive Pulmonary Aspergillosis (PP) | Success | 12 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Invasive Pulmonary Aspergillosis (PP) | Failure | 13 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Invasive Pulmonary Aspergillosis (PP) | Not Evaluable | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Other Emerging Fungi (ITT) | Success | 7 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Other Emerging Fungi (ITT) | Failure | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Other Emerging Fungi (ITT) | Not Evaluable | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Other Emerging Fungi (PP) | Success | 7 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Other Emerging Fungi (PP) | Failure | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease. | Other Emerging Fungi (PP) | Not Evaluable | 0 Participants |
Describe Ibrexafungerp Plasma Concentrations
Ibrexafungerp plasma concentrations measured at specified timepoints prior to and after administration of study drug for participants that received the following dose regimen: Day 1 and 2 loading dose - 750mg BID Day 3 onwards - 750mg QD
Time frame: Day 2 post-dose, Day 3-5 pre-dose, Dat 7-10 pre-dose.
Population: Pharmacokinetic (Pk) Population - all enrolled participants who provided at least one Pk sample and with no deviations significant enough to affect interpretation of the Pk data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ibrexafungerp (SCY-078) | Describe Ibrexafungerp Plasma Concentrations | Day 2 post-dose | 479 nanograms per milliliter (ng/mL) |
| Ibrexafungerp (SCY-078) | Describe Ibrexafungerp Plasma Concentrations | Day 3-5 pre-dose | 644 nanograms per milliliter (ng/mL) |
| Ibrexafungerp (SCY-078) | Describe Ibrexafungerp Plasma Concentrations | Day 7-10 pre-dose | 571 nanograms per milliliter (ng/mL) |
Percentage of Participants Surviving at Day 30 or Day 42
Percentage of participants with invasive candidiasis surviving at Day 30 post-Baseline or percentage of participants with other fungal diseases surviving at Day 42 post-Baseline.
Time frame: Day 30 post-Baseline for Invasive Candidiasis and Day 42 post-Baseline for all other fungal diseases.
Population: Intent to Treat (ITT) Population - any participant enrolled in the study who received at least one dose of study drug.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Candidemia | Dead | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Candidemia | Unknown | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Esophageal Candidiasis | Alive | 15 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Acute Invasive Candidiasis | Alive | 39 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Acute Invasive Candidiasis | Dead | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Acute Invasive Candidiasis | Unknown | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Chronic Invasive Candidiasis | Alive | 43 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Chronic Invasive Candidiasis | Dead | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Chronic Invasive Candidiasis | Unknown | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Candidemia | Alive | 17 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Esophageal Candidiasis | Dead | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Esophageal Candidiasis | Unknown | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Oropharyngeal Candidiasis | Alive | 14 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Oropharyngeal Candidiasis | Dead | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Oropharyngeal Candidiasis | Unknown | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Chronic Mucocutaneous Candidiasis | Alive | 13 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Chronic Mucocutaneous Candidiasis | Dead | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Chronic Mucocutaneous Candidiasis | Unknown | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Vulvovaginal Candidiasis | Alive | 32 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Vulvovaginal Candidiasis | Dead | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Vulvovaginal Candidiasis | Unknown | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Disseminated/Invasive Dimorphic Fungi | Alive | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Disseminated/Invasive Dimorphic Fungi | Dead | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Disseminated/Invasive Dimorphic Fungi | Unknown | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Chronic Pulmonary Aspergillosis | Alive | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Chronic Pulmonary Aspergillosis | Dead | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Chronic Pulmonary Aspergillosis | Unknown | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Allergic Bronchopulmonary Aspergillosis | Alive | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Allergic Bronchopulmonary Aspergillosis | Dead | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Allergic Bronchopulmonary Aspergillosis | Unknown | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Invasive Pulmonary Aspergillosis | Alive | 22 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Invasive Pulmonary Aspergillosis | Dead | 6 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Invasive Pulmonary Aspergillosis | Unknown | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Other Emerging Fungi | Alive | 10 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Other Emerging Fungi | Dead | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Surviving at Day 30 or Day 42 | Other Emerging Fungi | Unknown | 1 Participants |
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category.
The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by disease category. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Population: Intent to Treat (ITT) Population - all participants who were enrolled in the study and received at least one dose of study drug.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. | Invasive Candidiasis including Candidemia | Success | 70 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. | Invasive Candidiasis including Candidemia | Failure | 22 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. | Invasive Candidiasis including Candidemia | Not Evaluable | 12 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. | Mucocutaneous Candidiasis | Success | 52 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. | Mucocutaneous Candidiasis | Failure | 19 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. | Mucocutaneous Candidiasis | Not Evaluable | 4 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. | Dimorphic Fungi | Success | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. | Dimorphic Fungi | Failure | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. | Dimorphic Fungi | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. | Aspergillus Syndromes | Success | 12 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. | Aspergillus Syndromes | Failure | 23 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. | Aspergillus Syndromes | Not Evaluable | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. | Other emerging fungi | Success | 7 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. | Other emerging fungi | Failure | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category. | Other emerging fungi | Not Evaluable | 1 Participants |
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category
The percentage of participants who achieve a Global Response (defined as complete or partial response) as determined by the DRC by enrollment category, at disease specific timepoints. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Participants may have been enrolled for more than 1 enrollment reason.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Population: Intent to Treat (ITT) Population - all participants who were enrolled in the study and received at least one dose of study drug.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Refractory Fungal Infection | Success | 74 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Refractory Fungal Infection | Failure | 41 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Refractory Fungal Infection | Not Evaluable | 13 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Resistance to standard of care antifungal | Success | 95 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Resistance to standard of care antifungal | Failure | 29 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Resistance to standard of care antifungal | Not Evaluable | 10 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Intolerance to standard of care antifungal | Success | 13 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Intolerance to standard of care antifungal | Failure | 14 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Intolerance to standard of care antifungal | Not Evaluable | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Toxicities associated with standard of care antifungal | Success | 7 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Toxicities associated with standard of care antifungal | Failure | 8 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Toxicities associated with standard of care antifungal | Not Evaluable | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Relapse | Success | 12 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Relapse | Failure | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Relapse | Not Evaluable | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Other | Success | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Other | Failure | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category | Other | Not Evaluable | 1 Participants |
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category
The percentage of participants with a Clinical Response as determined by the DRC at disease specific timepoints, by disease category. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Population: Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Invasive Candidiasis including Candidemia | Success | 57 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Invasive Candidiasis including Candidemia | Failure | 16 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Invasive Candidiasis including Candidemia | Not Evaluable | 29 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Invasive Candidiasis including Candidemia | No Response | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Mucocutaneous Candidiasis (TOC) | Success | 25 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Mucocutaneous Candidiasis (TOC) | Failure | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Mucocutaneous Candidiasis (TOC) | Not Evaluable | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Mucocutaneous Candidiasis (TOC) | No Response | 43 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Dimorphic Fungi | Success | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Dimorphic Fungi | Failure | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Dimorphic Fungi | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Dimorphic Fungi | No Response | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Aspergillus Syndromes | Success | 18 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Aspergillus Syndromes | Failure | 14 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Aspergillus Syndromes | Not Evaluable | 6 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Aspergillus Syndromes | No Response | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Other emerging fungi | Success | 7 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Other emerging fungi | Failure | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Other emerging fungi | Not Evaluable | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category | Other emerging fungi | No Response | 0 Participants |
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen
The percentage of participants with a Clinical Response as determined by the DRC by disease category and by pathogen isolated, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Population: Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (other) | Not Evaluable/Missing | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. auris) | Success | 6 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. auris) | Failure | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. auris) | Not Evaluable/Missing | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. glabrata) | Success | 30 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. glabrata) | Failure | 6 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. glabrata) | Not Evaluable/Missing | 13 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. krusei) | Success | 4 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. krusei) | Failure | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. krusei) | Not Evaluable/Missing | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. parapsilosis) | Success | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. parapsilosis) | Failure | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. parapsilosis) | Not Evaluable/Missing | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. tropicalis) | Success | 6 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. tropicalis) | Failure | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. tropicalis) | Not Evaluable/Missing | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (other) | Success | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (other) | Failure | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. albicans) | Success | 19 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. albicans) | Failure | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. albicans) | Not Evaluable/Missing | 27 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. glabrata) | Success | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. glabrata) | Failure | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. glabrata) | Not Evaluable/Missing | 17 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. krusei) | Success | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. krusei) | Failure | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. krusei) | Not Evaluable/Missing | 4 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. tropicalis) | Success | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. tropicalis) | Failure | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. tropicalis) | Not Evaluable/Missing | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. parapsilosis) | Success | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. parapsilosis) | Failure | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. parapsilosis) | Not Evaluable/Missing | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Mucocutaneous Candidiasis (other) | Success | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Mucocutaneous Candidiasis (other) | Failure | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Mucocutaneous Candidiasis (other) | Not Evaluable/Missing | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Dimorphic Fungi (Histoplasmosis) | Success | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Dimorphic Fungi (Histoplasmosis) | Failure | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Dimorphic Fungi (Histoplasmosis) | Not Evaluable/Missing | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Aspergillus Syndromes (A. flavus) | Success | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Aspergillus Syndromes (A. flavus) | Failure | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Aspergillus Syndromes (A. flavus) | Not Evaluable/Missing | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Aspergillus Syndromes (A. fumigatus) | Success | 8 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Aspergillus Syndromes (A. fumigatus) | Failure | 8 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Aspergillus Syndromes (A. fumigatus) | Not Evaluable/Missing | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Aspergillus Syndromes (other) | Success | 9 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Aspergillus Syndromes (other) | Failure | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Aspergillus Syndromes (other) | Not Evaluable/Missing | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. albicans) | Success | 11 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. albicans) | Failure | 7 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. albicans) | Not Evaluable/Missing | 8 Participants |
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category
The percentage of participants with a Clinical Response as determined by the DRC by enrollment category, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Population: Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Relapse | Success | 8 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Refractory | Success | 57 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Refractory | Failure | 29 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Refractory | Not Evaluable | 13 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Refractory | No Response | 29 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Resistence | Success | 75 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Resistence | Failure | 23 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Resistence | Not Evaluable | 25 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Resistence | No Response | 11 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Intolerance | Success | 16 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Intolerance | Failure | 8 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Intolerance | Not Evaluable | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Toxicities | No Response | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Intolerance | No Response | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Toxicities | Success | 12 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Toxicities | Failure | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Toxicities | Not Evaluable | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Relapse | Failure | 4 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Relapse | Not Evaluable | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category | Relapse | No Response | 5 Participants |
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease
The percentage of participants with a Clinical Response as determined by the DRC by fungal disease, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Population: Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Acute Invasive Candidiasis, including Candidemia | Success | 30 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Acute Invasive Candidiasis, including Candidemia | Failure | 10 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Acute Invasive Candidiasis, including Candidemia | Not Evaluable | 19 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Acute Invasive Candidiasis, including Candidemia | No Response | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Chronic Invasive Candidiasis | Success | 27 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Chronic Invasive Candidiasis | Failure | 6 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Chronic Invasive Candidiasis | Not Evaluable | 10 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Chronic Invasive Candidiasis | No Response | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Vulvovaginal Candidiasis | Success | 25 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Vulvovaginal Candidiasis | Failure | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Vulvovaginal Candidiasis | Not Evaluable | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Vulvovaginal Candidiasis | No Response | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Esophageal Candidiasis | Success | 10 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Esophageal Candidiasis | Failure | 4 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Esophageal Candidiasis | Not Evaluable | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Esophageal Candidiasis | No Response | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Oropharyngeal Candidiasis | Success | 10 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Oropharyngeal Candidiasis | Failure | 4 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Oropharyngeal Candidiasis | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Oropharyngeal Candidiasis | No Response | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Chronic Mucocutaneous Candidiasis | Success | 8 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Chronic Mucocutaneous Candidiasis | Failure | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Chronic Mucocutaneous Candidiasis | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Chronic Mucocutaneous Candidiasis | No Response | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Disseminated/Invasive Dimorphic Fungi | Success | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Disseminated/Invasive Dimorphic Fungi | Failure | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Disseminated/Invasive Dimorphic Fungi | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Disseminated/Invasive Dimorphic Fungi | No Response | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Chronic Pulmonary Aspergillosis | Success | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Chronic Pulmonary Aspergillosis | Failure | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Chronic Pulmonary Aspergillosis | Not Evaluable | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Chronic Pulmonary Aspergillosis | No Response | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Allergic Bronchopulmonary Aspergillosis | Success | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Allergic Bronchopulmonary Aspergillosis | Failure | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Allergic Bronchopulmonary Aspergillosis | Not Evaluable | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Allergic Bronchopulmonary Aspergillosis | No Response | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Invasive Pulmonary Aspergillosis | Success | 15 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Invasive Pulmonary Aspergillosis | Failure | 10 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Invasive Pulmonary Aspergillosis | Not Evaluable | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Invasive Pulmonary Aspergillosis | No Response | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Other Emerging Fungi | Success | 7 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Other Emerging Fungi | Failure | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Other Emerging Fungi | Not Evaluable | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease | Other Emerging Fungi | No Response | 0 Participants |
Percentage of Participants With a Mycological Response by Disease Category
The percentage of participants with a Mycological Response as determined by the DRC by disease category, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Population: Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category | Dimorphic Fungi | Not Evaluable/Missing | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category | Invasive Candidiasis including Candidemia | Success | 20 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category | Invasive Candidiasis including Candidemia | Failure | 14 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category | Invasive Candidiasis including Candidemia | Not Evaluable/Missing | 70 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category | Mucocutaneous Candidiasis (TOC) | Success | 11 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category | Mucocutaneous Candidiasis (TOC) | Failure | 13 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category | Mucocutaneous Candidiasis (TOC) | Not Evaluable/Missing | 51 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category | Dimorphic Fungi | Success | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category | Dimorphic Fungi | Failure | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category | Aspergillus Syndromes | Success | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category | Aspergillus Syndromes | Failure | 13 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category | Aspergillus Syndromes | Not Evaluable/Missing | 22 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category | Other emerging fungi | Success | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category | Other emerging fungi | Failure | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category | Other emerging fungi | Not Evaluable/Missing | 7 Participants |
Percentage of Participants With a Mycological Response by Disease Category and Pathogen
The percentage of participants with a Mycological Response as determined by the DRC by disease category and by pathogen, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Population: Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. glabrata) | Success | 10 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (other) | Success | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Dimorphic Fungi (Histoplasmosis) | Not Evaluable/Missing | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. albicans) | Success | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. albicans) | Failure | 6 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. albicans) | Not Evaluable/Missing | 17 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. parapsilosis) | Success | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. parapsilosis) | Failure | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. parapsilosis) | Not Evaluable/Missing | 6 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. auris) | Success | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. auris) | Failure | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. auris) | Not Evaluable/Missing | 7 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. glabrata) | Failure | 7 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. glabrata) | Not Evaluable/Missing | 32 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. krusei) | Success | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. krusei) | Failure | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. krusei) | Not Evaluable/Missing | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. tropicalis) | Success | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. tropicalis) | Failure | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (C. tropicalis) | Not Evaluable/Missing | 7 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (other) | Failure | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Invasive Candidiasis, including Candidemia (other) | Not Evaluable/Missing | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. albicans) | Success | 10 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. albicans) | Failure | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. albicans) | Not Evaluable/Missing | 32 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. glabrata) | Success | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. krusei) | Success | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. glabrata) | Failure | 8 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. glabrata) | Not Evaluable/Missing | 17 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. krusei) | Failure | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. krusei) | Not Evaluable/Missing | 4 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. parapsilosis) | Success | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. parapsilosis) | Failure | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. parapsilosis) | Not Evaluable/Missing | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. tropicalis) | Success | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. tropicalis) | Failure | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Mucocutaneous Candidiasis (C. tropicalis) | Not Evaluable/Missing | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Mucocutaneous Candidiasis other) | Success | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Mucocutaneous Candidiasis other) | Failure | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Mucocutaneous Candidiasis other) | Not Evaluable/Missing | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Dimorphic Fungi (Coccidioidomycosis) | Success | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Dimorphic Fungi (Coccidioidomycosis) | Failure | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Dimorphic Fungi (Coccidioidomycosis) | Not Evaluable/Missing | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Dimorphic Fungi (Histoplasmosis) | Success | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Dimorphic Fungi (Histoplasmosis) | Failure | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Aspergillus Syndromes (A. nidulans) | Success | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Aspergillus Syndromes (A. nidulans) | Failure | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Aspergillus Syndromes (A. nidulans) | Not Evaluable/Missing | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Aspergillus Syndromes (A. fumigatus) | Success | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Aspergillus Syndromes (A. fumigatus) | Failure | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Aspergillus Syndromes (A. fumigatus) | Not Evaluable/Missing | 12 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Aspergillus Syndromes (A. flavus) | Success | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Aspergillus Syndromes (A. flavus) | Failure | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Aspergillus Syndromes (A. flavus) | Not Evaluable/Missing | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Aspergillus Syndromes (other) | Success | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Aspergillus Syndromes (other) | Failure | 7 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Disease Category and Pathogen | Aspergillus Syndromes (other) | Not Evaluable/Missing | 5 Participants |
Percentage of Participants With a Mycological Response by Enrollment Category
The percentage of participants with a Mycological Response as determined by the DRC by enrollment category, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Population: Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Enrollment Category | Refractory | Success | 21 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Enrollment Category | Refractory | Failure | 33 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Enrollment Category | Refractory | Not Evaluable/Failure | 74 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Enrollment Category | Resistence | Success | 28 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Enrollment Category | Resistence | Failure | 19 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Enrollment Category | Resistence | Not Evaluable/Failure | 87 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Enrollment Category | Intolerance | Success | 7 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Enrollment Category | Intolerance | Failure | 10 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Enrollment Category | Intolerance | Not Evaluable/Failure | 12 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Enrollment Category | Toxicities | Success | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Enrollment Category | Toxicities | Failure | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Enrollment Category | Toxicities | Not Evaluable/Failure | 11 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Enrollment Category | Relapse | Success | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Enrollment Category | Relapse | Failure | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Enrollment Category | Relapse | Not Evaluable/Failure | 11 Participants |
Percentage of Participants With a Mycological Response by Fungal Disease
The percentage of participants with a Mycological Response as determined by the DRC by fungal disease, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Population: Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Acute Invasive Candidiasis, including Candidemia | Success | 16 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Acute Invasive Candidiasis, including Candidemia | Failure | 10 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Acute Invasive Candidiasis, including Candidemia | Not Evaluable/Missing | 35 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Chronic Invasive Candidiasis | Success | 4 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Chronic Invasive Candidiasis | Failure | 4 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Chronic Invasive Candidiasis | Not Evaluable/Missing | 35 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Esophageal Candidiasis | Success | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Esophageal Candidiasis | Failure | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Esophageal Candidiasis | Not Evaluable/Missing | 9 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Oropharyngeal Candidiasis | Success | 7 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Oropharyngeal Candidiasis | Failure | 4 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Oropharyngeal Candidiasis | Not Evaluable/Missing | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Chronic Mucocutaneous Candidiasis | Success | 6 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Chronic Mucocutaneous Candidiasis | Failure | 6 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Chronic Mucocutaneous Candidiasis | Not Evaluable/Missing | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Vulvovaginal Candidiasis | Success | 11 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Vulvovaginal Candidiasis | Failure | 13 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Vulvovaginal Candidiasis | Not Evaluable/Missing | 8 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Disseminated/Invasive Dimorphic Fungi | Success | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Disseminated/Invasive Dimorphic Fungi | Failure | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Disseminated/Invasive Dimorphic Fungi | Not Evaluable/Missing | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Chronic Pulmonary Aspergillosis | Success | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Chronic Pulmonary Aspergillosis | Failure | 4 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Chronic Pulmonary Aspergillosis | Not Evaluable/Missing | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Allergic Bronchopulmonary Aspergillosis | Success | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Allergic Bronchopulmonary Aspergillosis | Failure | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Allergic Bronchopulmonary Aspergillosis | Not Evaluable/Missing | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Invasive Pulmonary Aspergillosis | Success | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Invasive Pulmonary Aspergillosis | Failure | 7 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Invasive Pulmonary Aspergillosis | Not Evaluable/Missing | 19 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Other Emerging Fungi | Success | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Other Emerging Fungi | Failure | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Mycological Response by Fungal Disease | Other Emerging Fungi | Not Evaluable/Missing | 7 Participants |
Percentage of Participants With a Recurrence of Baseline Fungal Disease
The percentage of participants with a recurrence of their baseline fungal disease as assessed by the DRC at the 25-Day Follow Up (FU) for Vulvovaginal Candidiasis and at the 6-Week FU for all other diseases as assessed by the DRC. Recurrence is defined as having Global Response at end of treatment or test of cure, but re-emergence of the baseline fungal disease during the post treatment follow-up. Re-emergence is required to be with the same species and involving the same site identified at baseline.
Time frame: 42 days for vulvovaginal candidiasis and 6 weeks after End of Treatment (up to 180 days after treatment start) for all other diseases.
Population: Intent to Treat (ITT) population (any participant who was enrolled in the study and received at least one dose of study drug) that achieved a Global Response.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Acute Invasive Candidiasis including Candidemia | Recurrence | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Acute Invasive Candidiasis including Candidemia | No Recurrence | 35 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Acute Invasive Candidiasis including Candidemia | Not Evaluable | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Chronic Invasive Candidasis | Recurrence | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Chronic Invasive Candidasis | No Recurrence | 29 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Chronic Invasive Candidasis | Not Evaluable | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Candidemia only | Recurrence | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Candidemia only | No Recurrence | 11 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Candidemia only | Not Evaluable | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Esophageal Candidiasis | Recurrence | 3 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Esophageal Candidiasis | No Recurrence | 5 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Esophageal Candidiasis | Not Evaluable | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Oropharyngeal Candidiasis | Recurrence | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Oropharyngeal Candidiasis | No Recurrence | 7 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Oropharyngeal Candidiasis | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Chronic Mucotaneous Candidiasis | Recurrence | 4 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Chronic Mucotaneous Candidiasis | No Recurrence | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Chronic Mucotaneous Candidiasis | Not Evaluable | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Vulvovaginal Candidiasis | Recurrence | 6 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Vulvovaginal Candidiasis | No Recurrence | 18 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Vulvovaginal Candidiasis | Not Evaluable | 4 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Disseminated/Invasive Dimorphic Fungi | Recurrence | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Disseminated/Invasive Dimorphic Fungi | No Recurrence | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Disseminated/Invasive Dimorphic Fungi | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Chronic Pulmonary Aspergillosis | Recurrence | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Chronic Pulmonary Aspergillosis | No Recurrence | 1 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Chronic Pulmonary Aspergillosis | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Allergic Bronchopulmonary Aspergillosis | Recurrence | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Allergic Bronchopulmonary Aspergillosis | No Recurrence | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Allergic Bronchopulmonary Aspergillosis | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Invasive Pulmonary Aspergillosis | Recurrence | 2 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Invasive Pulmonary Aspergillosis | No Recurrence | 10 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Invasive Pulmonary Aspergillosis | Not Evaluable | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Other | Recurrence | 0 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Other | No Recurrence | 6 Participants |
| Ibrexafungerp (SCY-078) | Percentage of Participants With a Recurrence of Baseline Fungal Disease | Other | Not Evaluable | 1 Participants |
Time to Death From Any Cause
Time to death from any cause in days per Fungal Disease
Time frame: Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Population: Safety Population - All subjects who received at least one dose of study drug and who had at least one safety assessment post-Baseline.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ibrexafungerp (SCY-078) | Time to Death From Any Cause | Acute Invasive Candidiasis | NA Number of days |
| Ibrexafungerp (SCY-078) | Time to Death From Any Cause | Candidemia | NA Number of days |
| Ibrexafungerp (SCY-078) | Time to Death From Any Cause | Chronic Invasive Candidiasis | NA Number of days |
| Ibrexafungerp (SCY-078) | Time to Death From Any Cause | Vulvovaginal Candidiasis | NA Number of days |
| Ibrexafungerp (SCY-078) | Time to Death From Any Cause | Esophageal Candidiasis | NA Number of days |
| Ibrexafungerp (SCY-078) | Time to Death From Any Cause | Oropharyngeal Candidiasis | NA Number of days |
| Ibrexafungerp (SCY-078) | Time to Death From Any Cause | Chronic Mucocutaneous Candidiasis | NA Number of days |
| Ibrexafungerp (SCY-078) | Time to Death From Any Cause | Diffuse/Invasive Dimorphic Fungi | NA Number of days |
| Ibrexafungerp (SCY-078) | Time to Death From Any Cause | Chronic Pulmonary Aspergillosis | NA Number of days |
| Ibrexafungerp (SCY-078) | Time to Death From Any Cause | Allergic Bronchopulmonary Aspergillosis | NA Number of days |
| Ibrexafungerp (SCY-078) | Time to Death From Any Cause | Invasive Pulmonary Aspergillosis | 282 Number of days |
| Ibrexafungerp (SCY-078) | Time to Death From Any Cause | Other Emerging Fungi | 270 Number of days |