Skip to content

Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment

Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 (Ibrexafungerp) in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment (FURI)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03059992
Acronym
FURI
Enrollment
233
Registered
2017-02-23
Start date
2017-04-01
Completion date
2023-08-25
Last updated
2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Bronchopulmonary Aspergillosis, Blastomycosis, Chronic Pulmonary Aspergillosis, Coccidioidomycosis, Histoplasmosis, Invasive Candidiasis, Invasive Pulmonary Aspergillosis, Mucocutaneous Candidiasis, Other Emerging Fungi, Recurrent Vulvovaginal Candidiasis

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

Scynexis, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Open label, non-comparator, single arm

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
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

MeasureTime frameDescription
Describe Ibrexafungerp Plasma ConcentrationsDay 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 CategoryVulvovaginal 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 CategoryVulvovaginal 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 PathogenVulvovaginal 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 DiseaseVulvovaginal 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 CauseSix 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 CategoryVulvovaginal 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 PathogenVulvovaginal 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 DiseaseVulvovaginal 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 CategoryVulvovaginal 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 Disease42 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 42Day 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 CategoryVulvovaginal 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

ArmCount
Ibrexafungerp (SCY-078)
Ibrexafungerp (SCY-078), orally administered QD for up to 180 days.
233
Total233

Baseline characteristics

CharacteristicIbrexafungerp (SCY-078)
Age, Continuous53.6 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 typeEG000
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

Primary

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.

ArmMeasureGroupCategoryValue (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)Success142 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)Failure69 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 Evaluable22 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)Success131 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)Failure59 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 Evaluable5 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)Success40 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)Failure13 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 Evaluable8 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)Success37 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)Failure10 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 Evaluable2 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)Success30 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)Failure9 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 Evaluable4 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)Success25 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)Failure7 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 Evaluable1 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)Success9 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)Failure5 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 Evaluable2 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)Success9 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)Failure4 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 Evaluable1 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)Success9 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)Failure5 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 Evaluable0 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)Success8 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)Failure5 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 Evaluable0 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)Success8 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)Failure5 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 Evaluable0 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)Success8 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)Failure4 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 Evaluable0 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)Success26 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)Failure4 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 Evaluable2 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)Success24 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)Failure3 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 Evaluable0 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)Success1 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)Failure2 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 Evaluable0 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)Success1 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)Failure2 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 Evaluable0 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)Success0 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)Failure6 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 Evaluable0 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)Success0 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)Failure5 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 Evaluable0 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)Success0 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)Failure3 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 Evaluable2 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)Success0 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)Failure3 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 Evaluable0 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)Success12 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)Failure14 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 Evaluable3 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)Success12 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)Failure13 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 Evaluable1 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)Success7 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)Failure3 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 Evaluable1 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)Success7 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)Failure3 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 Evaluable0 Participants
Secondary

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.

ArmMeasureGroupValue (MEDIAN)
Ibrexafungerp (SCY-078)Describe Ibrexafungerp Plasma ConcentrationsDay 2 post-dose479 nanograms per milliliter (ng/mL)
Ibrexafungerp (SCY-078)Describe Ibrexafungerp Plasma ConcentrationsDay 3-5 pre-dose644 nanograms per milliliter (ng/mL)
Ibrexafungerp (SCY-078)Describe Ibrexafungerp Plasma ConcentrationsDay 7-10 pre-dose571 nanograms per milliliter (ng/mL)
Secondary

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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42CandidemiaDead1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42CandidemiaUnknown2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Esophageal CandidiasisAlive15 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Acute Invasive CandidiasisAlive39 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Acute Invasive CandidiasisDead1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Acute Invasive CandidiasisUnknown1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Chronic Invasive CandidiasisAlive43 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Chronic Invasive CandidiasisDead0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Chronic Invasive CandidiasisUnknown0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42CandidemiaAlive17 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Esophageal CandidiasisDead0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Esophageal CandidiasisUnknown1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Oropharyngeal CandidiasisAlive14 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Oropharyngeal CandidiasisDead0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Oropharyngeal CandidiasisUnknown0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Chronic Mucocutaneous CandidiasisAlive13 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Chronic Mucocutaneous CandidiasisDead0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Chronic Mucocutaneous CandidiasisUnknown0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Vulvovaginal CandidiasisAlive32 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Vulvovaginal CandidiasisDead0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Vulvovaginal CandidiasisUnknown0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Disseminated/Invasive Dimorphic FungiAlive3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Disseminated/Invasive Dimorphic FungiDead0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Disseminated/Invasive Dimorphic FungiUnknown0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Chronic Pulmonary AspergillosisAlive5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Chronic Pulmonary AspergillosisDead0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Chronic Pulmonary AspergillosisUnknown1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Allergic Bronchopulmonary AspergillosisAlive5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Allergic Bronchopulmonary AspergillosisDead0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Allergic Bronchopulmonary AspergillosisUnknown0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Invasive Pulmonary AspergillosisAlive22 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Invasive Pulmonary AspergillosisDead6 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Invasive Pulmonary AspergillosisUnknown1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Other Emerging FungiAlive10 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Other Emerging FungiDead0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Surviving at Day 30 or Day 42Other Emerging FungiUnknown1 Participants
Secondary

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.

ArmMeasureGroupCategoryValue (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 CandidemiaSuccess70 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 CandidemiaFailure22 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 CandidemiaNot Evaluable12 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category.Mucocutaneous CandidiasisSuccess52 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category.Mucocutaneous CandidiasisFailure19 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category.Mucocutaneous CandidiasisNot Evaluable4 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category.Dimorphic FungiSuccess1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category.Dimorphic FungiFailure2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category.Dimorphic FungiNot Evaluable0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category.Aspergillus SyndromesSuccess12 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category.Aspergillus SyndromesFailure23 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category.Aspergillus SyndromesNot Evaluable5 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 fungiSuccess7 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 fungiFailure3 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 fungiNot Evaluable1 Participants
Secondary

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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment CategoryRefractory Fungal InfectionSuccess74 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment CategoryRefractory Fungal InfectionFailure41 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment CategoryRefractory Fungal InfectionNot Evaluable13 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment CategoryResistance to standard of care antifungalSuccess95 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment CategoryResistance to standard of care antifungalFailure29 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment CategoryResistance to standard of care antifungalNot Evaluable10 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment CategoryIntolerance to standard of care antifungalSuccess13 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment CategoryIntolerance to standard of care antifungalFailure14 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment CategoryIntolerance to standard of care antifungalNot Evaluable2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment CategoryToxicities associated with standard of care antifungalSuccess7 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment CategoryToxicities associated with standard of care antifungalFailure8 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment CategoryToxicities associated with standard of care antifungalNot Evaluable2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment CategoryRelapseSuccess12 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment CategoryRelapseFailure5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment CategoryRelapseNot Evaluable1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment CategoryOtherSuccess0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment CategoryOtherFailure1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment CategoryOtherNot Evaluable1 Participants
Secondary

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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryInvasive Candidiasis including CandidemiaSuccess57 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryInvasive Candidiasis including CandidemiaFailure16 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryInvasive Candidiasis including CandidemiaNot Evaluable29 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryInvasive Candidiasis including CandidemiaNo Response2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryMucocutaneous Candidiasis (TOC)Success25 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryMucocutaneous Candidiasis (TOC)Failure5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryMucocutaneous Candidiasis (TOC)Not Evaluable2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryMucocutaneous Candidiasis (TOC)No Response43 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryDimorphic FungiSuccess3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryDimorphic FungiFailure0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryDimorphic FungiNot Evaluable0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryDimorphic FungiNo Response0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryAspergillus SyndromesSuccess18 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryAspergillus SyndromesFailure14 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryAspergillus SyndromesNot Evaluable6 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryAspergillus SyndromesNo Response2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryOther emerging fungiSuccess7 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryOther emerging fungiFailure3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryOther emerging fungiNot Evaluable1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease CategoryOther emerging fungiNo Response0 Participants
Secondary

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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (other)Not Evaluable/Missing2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. auris)Success6 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. auris)Failure1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. auris)Not Evaluable/Missing3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. glabrata)Success30 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. glabrata)Failure6 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. glabrata)Not Evaluable/Missing13 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. krusei)Success4 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. krusei)Failure2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. krusei)Not Evaluable/Missing2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. parapsilosis)Success5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. parapsilosis)Failure1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. parapsilosis)Not Evaluable/Missing3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. tropicalis)Success6 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. tropicalis)Failure0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. tropicalis)Not Evaluable/Missing3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (other)Success3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (other)Failure0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenMucocutaneous Candidiasis (C. albicans)Success19 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenMucocutaneous Candidiasis (C. albicans)Failure1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenMucocutaneous Candidiasis (C. albicans)Not Evaluable/Missing27 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenMucocutaneous Candidiasis (C. glabrata)Success5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenMucocutaneous Candidiasis (C. glabrata)Failure3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenMucocutaneous Candidiasis (C. glabrata)Not Evaluable/Missing17 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenMucocutaneous Candidiasis (C. krusei)Success2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenMucocutaneous Candidiasis (C. krusei)Failure1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenMucocutaneous Candidiasis (C. krusei)Not Evaluable/Missing4 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenMucocutaneous Candidiasis (C. tropicalis)Success0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenMucocutaneous Candidiasis (C. tropicalis)Failure0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenMucocutaneous Candidiasis (C. tropicalis)Not Evaluable/Missing1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenMucocutaneous Candidiasis (C. parapsilosis)Success1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenMucocutaneous Candidiasis (C. parapsilosis)Failure0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenMucocutaneous Candidiasis (C. parapsilosis)Not Evaluable/Missing0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenMucocutaneous Candidiasis (other)Success3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenMucocutaneous Candidiasis (other)Failure1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenMucocutaneous Candidiasis (other)Not Evaluable/Missing5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenDimorphic Fungi (Histoplasmosis)Success3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenDimorphic Fungi (Histoplasmosis)Failure0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenDimorphic Fungi (Histoplasmosis)Not Evaluable/Missing0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenAspergillus Syndromes (A. flavus)Success2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenAspergillus Syndromes (A. flavus)Failure0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenAspergillus Syndromes (A. flavus)Not Evaluable/Missing0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenAspergillus Syndromes (A. fumigatus)Success8 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenAspergillus Syndromes (A. fumigatus)Failure8 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenAspergillus Syndromes (A. fumigatus)Not Evaluable/Missing2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenAspergillus Syndromes (other)Success9 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenAspergillus Syndromes (other)Failure5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenAspergillus Syndromes (other)Not Evaluable/Missing0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. albicans)Success11 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. albicans)Failure7 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. albicans)Not Evaluable/Missing8 Participants
Secondary

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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryRelapseSuccess8 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryRefractorySuccess57 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryRefractoryFailure29 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryRefractoryNot Evaluable13 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryRefractoryNo Response29 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryResistenceSuccess75 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryResistenceFailure23 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryResistenceNot Evaluable25 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryResistenceNo Response11 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryIntoleranceSuccess16 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryIntoleranceFailure8 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryIntoleranceNot Evaluable3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryToxicitiesNo Response1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryIntoleranceNo Response2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryToxicitiesSuccess12 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryToxicitiesFailure3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryToxicitiesNot Evaluable1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryRelapseFailure4 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryRelapseNot Evaluable1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment CategoryRelapseNo Response5 Participants
Secondary

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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseAcute Invasive Candidiasis, including CandidemiaSuccess30 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseAcute Invasive Candidiasis, including CandidemiaFailure10 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseAcute Invasive Candidiasis, including CandidemiaNot Evaluable19 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseAcute Invasive Candidiasis, including CandidemiaNo Response2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseChronic Invasive CandidiasisSuccess27 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseChronic Invasive CandidiasisFailure6 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseChronic Invasive CandidiasisNot Evaluable10 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseChronic Invasive CandidiasisNo Response0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseVulvovaginal CandidiasisSuccess25 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseVulvovaginal CandidiasisFailure5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseVulvovaginal CandidiasisNot Evaluable2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseVulvovaginal CandidiasisNo Response0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseEsophageal CandidiasisSuccess10 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseEsophageal CandidiasisFailure4 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseEsophageal CandidiasisNot Evaluable2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseEsophageal CandidiasisNo Response0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseOropharyngeal CandidiasisSuccess10 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseOropharyngeal CandidiasisFailure4 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseOropharyngeal CandidiasisNot Evaluable0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseOropharyngeal CandidiasisNo Response0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseChronic Mucocutaneous CandidiasisSuccess8 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseChronic Mucocutaneous CandidiasisFailure5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseChronic Mucocutaneous CandidiasisNot Evaluable0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseChronic Mucocutaneous CandidiasisNo Response0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseDisseminated/Invasive Dimorphic FungiSuccess3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseDisseminated/Invasive Dimorphic FungiFailure0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseDisseminated/Invasive Dimorphic FungiNot Evaluable0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseDisseminated/Invasive Dimorphic FungiNo Response0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseChronic Pulmonary AspergillosisSuccess3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseChronic Pulmonary AspergillosisFailure2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseChronic Pulmonary AspergillosisNot Evaluable1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseChronic Pulmonary AspergillosisNo Response0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseAllergic Bronchopulmonary AspergillosisSuccess0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseAllergic Bronchopulmonary AspergillosisFailure2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseAllergic Bronchopulmonary AspergillosisNot Evaluable2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseAllergic Bronchopulmonary AspergillosisNo Response1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseInvasive Pulmonary AspergillosisSuccess15 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseInvasive Pulmonary AspergillosisFailure10 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseInvasive Pulmonary AspergillosisNot Evaluable3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseInvasive Pulmonary AspergillosisNo Response1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseOther Emerging FungiSuccess7 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseOther Emerging FungiFailure3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseOther Emerging FungiNot Evaluable1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal DiseaseOther Emerging FungiNo Response0 Participants
Secondary

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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease CategoryDimorphic FungiNot Evaluable/Missing2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease CategoryInvasive Candidiasis including CandidemiaSuccess20 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease CategoryInvasive Candidiasis including CandidemiaFailure14 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease CategoryInvasive Candidiasis including CandidemiaNot Evaluable/Missing70 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease CategoryMucocutaneous Candidiasis (TOC)Success11 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease CategoryMucocutaneous Candidiasis (TOC)Failure13 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease CategoryMucocutaneous Candidiasis (TOC)Not Evaluable/Missing51 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease CategoryDimorphic FungiSuccess0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease CategoryDimorphic FungiFailure1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease CategoryAspergillus SyndromesSuccess5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease CategoryAspergillus SyndromesFailure13 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease CategoryAspergillus SyndromesNot Evaluable/Missing22 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease CategoryOther emerging fungiSuccess2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease CategoryOther emerging fungiFailure2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease CategoryOther emerging fungiNot Evaluable/Missing7 Participants
Secondary

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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. glabrata)Success10 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (other)Success0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenDimorphic Fungi (Histoplasmosis)Not Evaluable/Missing2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. albicans)Success3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. albicans)Failure6 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. albicans)Not Evaluable/Missing17 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. parapsilosis)Success1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. parapsilosis)Failure2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. parapsilosis)Not Evaluable/Missing6 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. auris)Success2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. auris)Failure1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. auris)Not Evaluable/Missing7 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. glabrata)Failure7 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. glabrata)Not Evaluable/Missing32 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. krusei)Success5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. krusei)Failure0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. krusei)Not Evaluable/Missing3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. tropicalis)Success2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. tropicalis)Failure0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (C. tropicalis)Not Evaluable/Missing7 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (other)Failure0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenInvasive Candidiasis, including Candidemia (other)Not Evaluable/Missing5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenMucocutaneous Candidiasis (C. albicans)Success10 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenMucocutaneous Candidiasis (C. albicans)Failure5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenMucocutaneous Candidiasis (C. albicans)Not Evaluable/Missing32 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenMucocutaneous Candidiasis (C. glabrata)Success0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenMucocutaneous Candidiasis (C. krusei)Success2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenMucocutaneous Candidiasis (C. glabrata)Failure8 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenMucocutaneous Candidiasis (C. glabrata)Not Evaluable/Missing17 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenMucocutaneous Candidiasis (C. krusei)Failure1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenMucocutaneous Candidiasis (C. krusei)Not Evaluable/Missing4 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenMucocutaneous Candidiasis (C. parapsilosis)Success0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenMucocutaneous Candidiasis (C. parapsilosis)Failure0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenMucocutaneous Candidiasis (C. parapsilosis)Not Evaluable/Missing1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenMucocutaneous Candidiasis (C. tropicalis)Success0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenMucocutaneous Candidiasis (C. tropicalis)Failure0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenMucocutaneous Candidiasis (C. tropicalis)Not Evaluable/Missing1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenMucocutaneous Candidiasis other)Success2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenMucocutaneous Candidiasis other)Failure2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenMucocutaneous Candidiasis other)Not Evaluable/Missing5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenDimorphic Fungi (Coccidioidomycosis)Success0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenDimorphic Fungi (Coccidioidomycosis)Failure0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenDimorphic Fungi (Coccidioidomycosis)Not Evaluable/Missing0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenDimorphic Fungi (Histoplasmosis)Success0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenDimorphic Fungi (Histoplasmosis)Failure1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenAspergillus Syndromes (A. nidulans)Success0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenAspergillus Syndromes (A. nidulans)Failure1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenAspergillus Syndromes (A. nidulans)Not Evaluable/Missing0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenAspergillus Syndromes (A. fumigatus)Success1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenAspergillus Syndromes (A. fumigatus)Failure5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenAspergillus Syndromes (A. fumigatus)Not Evaluable/Missing12 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenAspergillus Syndromes (A. flavus)Success1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenAspergillus Syndromes (A. flavus)Failure1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenAspergillus Syndromes (A. flavus)Not Evaluable/Missing0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenAspergillus Syndromes (other)Success2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenAspergillus Syndromes (other)Failure7 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Disease Category and PathogenAspergillus Syndromes (other)Not Evaluable/Missing5 Participants
Secondary

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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Enrollment CategoryRefractorySuccess21 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Enrollment CategoryRefractoryFailure33 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Enrollment CategoryRefractoryNot Evaluable/Failure74 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Enrollment CategoryResistenceSuccess28 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Enrollment CategoryResistenceFailure19 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Enrollment CategoryResistenceNot Evaluable/Failure87 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Enrollment CategoryIntoleranceSuccess7 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Enrollment CategoryIntoleranceFailure10 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Enrollment CategoryIntoleranceNot Evaluable/Failure12 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Enrollment CategoryToxicitiesSuccess1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Enrollment CategoryToxicitiesFailure5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Enrollment CategoryToxicitiesNot Evaluable/Failure11 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Enrollment CategoryRelapseSuccess5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Enrollment CategoryRelapseFailure2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Enrollment CategoryRelapseNot Evaluable/Failure11 Participants
Secondary

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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseAcute Invasive Candidiasis, including CandidemiaSuccess16 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseAcute Invasive Candidiasis, including CandidemiaFailure10 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseAcute Invasive Candidiasis, including CandidemiaNot Evaluable/Missing35 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseChronic Invasive CandidiasisSuccess4 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseChronic Invasive CandidiasisFailure4 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseChronic Invasive CandidiasisNot Evaluable/Missing35 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseEsophageal CandidiasisSuccess2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseEsophageal CandidiasisFailure5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseEsophageal CandidiasisNot Evaluable/Missing9 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseOropharyngeal CandidiasisSuccess7 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseOropharyngeal CandidiasisFailure4 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseOropharyngeal CandidiasisNot Evaluable/Missing3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseChronic Mucocutaneous CandidiasisSuccess6 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseChronic Mucocutaneous CandidiasisFailure6 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseChronic Mucocutaneous CandidiasisNot Evaluable/Missing1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseVulvovaginal CandidiasisSuccess11 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseVulvovaginal CandidiasisFailure13 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseVulvovaginal CandidiasisNot Evaluable/Missing8 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseDisseminated/Invasive Dimorphic FungiSuccess0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseDisseminated/Invasive Dimorphic FungiFailure1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseDisseminated/Invasive Dimorphic FungiNot Evaluable/Missing2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseChronic Pulmonary AspergillosisSuccess1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseChronic Pulmonary AspergillosisFailure4 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseChronic Pulmonary AspergillosisNot Evaluable/Missing1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseAllergic Bronchopulmonary AspergillosisSuccess1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseAllergic Bronchopulmonary AspergillosisFailure2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseAllergic Bronchopulmonary AspergillosisNot Evaluable/Missing2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseInvasive Pulmonary AspergillosisSuccess3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseInvasive Pulmonary AspergillosisFailure7 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseInvasive Pulmonary AspergillosisNot Evaluable/Missing19 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseOther Emerging FungiSuccess2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseOther Emerging FungiFailure2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Mycological Response by Fungal DiseaseOther Emerging FungiNot Evaluable/Missing7 Participants
Secondary

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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseAcute Invasive Candidiasis including CandidemiaRecurrence0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseAcute Invasive Candidiasis including CandidemiaNo Recurrence35 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseAcute Invasive Candidiasis including CandidemiaNot Evaluable5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseChronic Invasive CandidasisRecurrence0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseChronic Invasive CandidasisNo Recurrence29 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseChronic Invasive CandidasisNot Evaluable1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseCandidemia onlyRecurrence0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseCandidemia onlyNo Recurrence11 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseCandidemia onlyNot Evaluable2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseEsophageal CandidiasisRecurrence3 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseEsophageal CandidiasisNo Recurrence5 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseEsophageal CandidiasisNot Evaluable1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseOropharyngeal CandidiasisRecurrence2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseOropharyngeal CandidiasisNo Recurrence7 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseOropharyngeal CandidiasisNot Evaluable0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseChronic Mucotaneous CandidiasisRecurrence4 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseChronic Mucotaneous CandidiasisNo Recurrence2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseChronic Mucotaneous CandidiasisNot Evaluable1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseVulvovaginal CandidiasisRecurrence6 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseVulvovaginal CandidiasisNo Recurrence18 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseVulvovaginal CandidiasisNot Evaluable4 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseDisseminated/Invasive Dimorphic FungiRecurrence1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseDisseminated/Invasive Dimorphic FungiNo Recurrence0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseDisseminated/Invasive Dimorphic FungiNot Evaluable0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseChronic Pulmonary AspergillosisRecurrence0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseChronic Pulmonary AspergillosisNo Recurrence1 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseChronic Pulmonary AspergillosisNot Evaluable0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseAllergic Bronchopulmonary AspergillosisRecurrence0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseAllergic Bronchopulmonary AspergillosisNo Recurrence0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseAllergic Bronchopulmonary AspergillosisNot Evaluable0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseInvasive Pulmonary AspergillosisRecurrence2 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseInvasive Pulmonary AspergillosisNo Recurrence10 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseInvasive Pulmonary AspergillosisNot Evaluable0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseOtherRecurrence0 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseOtherNo Recurrence6 Participants
Ibrexafungerp (SCY-078)Percentage of Participants With a Recurrence of Baseline Fungal DiseaseOtherNot Evaluable1 Participants
Secondary

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.

ArmMeasureGroupValue (MEDIAN)
Ibrexafungerp (SCY-078)Time to Death From Any CauseAcute Invasive CandidiasisNA Number of days
Ibrexafungerp (SCY-078)Time to Death From Any CauseCandidemiaNA Number of days
Ibrexafungerp (SCY-078)Time to Death From Any CauseChronic Invasive CandidiasisNA Number of days
Ibrexafungerp (SCY-078)Time to Death From Any CauseVulvovaginal CandidiasisNA Number of days
Ibrexafungerp (SCY-078)Time to Death From Any CauseEsophageal CandidiasisNA Number of days
Ibrexafungerp (SCY-078)Time to Death From Any CauseOropharyngeal CandidiasisNA Number of days
Ibrexafungerp (SCY-078)Time to Death From Any CauseChronic Mucocutaneous CandidiasisNA Number of days
Ibrexafungerp (SCY-078)Time to Death From Any CauseDiffuse/Invasive Dimorphic FungiNA Number of days
Ibrexafungerp (SCY-078)Time to Death From Any CauseChronic Pulmonary AspergillosisNA Number of days
Ibrexafungerp (SCY-078)Time to Death From Any CauseAllergic Bronchopulmonary AspergillosisNA Number of days
Ibrexafungerp (SCY-078)Time to Death From Any CauseInvasive Pulmonary Aspergillosis282 Number of days
Ibrexafungerp (SCY-078)Time to Death From Any CauseOther Emerging Fungi270 Number of days

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026