Candidemia, Candidiasis, Invasive
Conditions
Keywords
Candida auris
Brief summary
This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (pharmacokinetics) of oral SCY-078 as an emergency use treatment for patients with a documented Candida auris infection.
Detailed description
This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (for a subset of subjects) of oral SCY-078 in male and female subjects ≥18 years of age with a documented Candida auris infection. Patients will be treated with SCY-078 for up to 90 days. Subjects must have a documented candidiasis, including candidemia, caused by Candida auris to be considered for enrollment. Subjects are also eligible if they are receiving intravenous (IV) antifungal therapy for their C. auris infection and, in the judgment of the investigator, continued IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances. Subjects must meet all study criteria to be eligible for inclusion. Inclusion of each subject in the study must be approved by the Sponsor prior to enrollment. Following a screening visit , there will be up to 11 treatment visits, a follow-up visit and 2 follow-up contacts (survival visits)
Interventions
DRUGSCY-078
Oral SCY-078
Sponsors
Scynexis, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
non comparator, single arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must fulfill the following KEY criteria to be eligible for study admission: 1. Subject is a male or female adult ≥ 18 years of age on the day the study informed consent form (ICF) is signed. 2. Subject has a documented candidiasis, including candidemia, caused by Candida auris. The subject is also eligible if he/she is receiving IV antifungal therapy for their C. auris infection and, in the judgment of the investigator, long-term IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances. A documented candidiasis, including candidemia, caused by Candida auris is defined as the recovery of Candida auris by culture of a sample obtained within the last 7 days. 3. Subject is able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube.
Exclusion criteria
* KEY
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee | At (EoT) Visit (up to 90 days after Day 1) | The percentage of participants with global success at End of Treatment (EoT) as determined by the Data Monitoring Committee. Global success is defined as complete or partial resolution of signs and symptoms associated with the fungal disease and mycological eradication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With Treatment-emergent Adverse Events | Through study completion, up to 132 days | Percent of participants with treatment-emergent Adverse Events (TEAEs) |
| Number of Participants Discontinued Due to Adverse Events | Through study completion (up to 132 Days) | Number of participants with Discontinuations due to Adverse Events |
| Percentage of Participants With Recurrence of Baseline Fungal Infection | 42 Days after the End of Treatment visit | The percentage of participants with a recurrence of the baseline fungal infection at the 6 week follow-up |
| Percentage of Participants Surviving 42 and 84 Days | Day 42 and Day 84 after first dose of study drug | Percentage of participants Surviving at Day 42 and Day 84 after Day 1 (first dose of study drug) |
Countries
India, Pakistan, South Africa, United States
Participant flow
Pre-assignment details
Of the 34 Participants Screened, 30 met the selection criteria for the study
Participants by arm
| Arm | Count |
|---|---|
| Ibrexafungerp 750 mg Oral ibrexafungerp was to be given as 750 mg BID (total daily dose = 1500 mg) on Days 1 and 2, followed by oral ibrexafungerp 750 mg QD (total daily dose = 750 mg) from Day 3 onwards for up to 90 days | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 7 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Ibrexafungerp 750 mg |
|---|---|
| Age, Continuous | 60.3 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 20 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 30 |
| other Total, other adverse events | 25 / 30 |
| serious Total, serious adverse events | 11 / 30 |
Outcome results
Primary
Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee
The percentage of participants with global success at End of Treatment (EoT) as determined by the Data Monitoring Committee. Global success is defined as complete or partial resolution of signs and symptoms associated with the fungal disease and mycological eradication.
Time frame: At (EoT) Visit (up to 90 days after Day 1)
Population: Intent to Treat Population (ITT): all subjects who were enrolled in the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ibrexafungerp 750mg | Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee | 21 Participants |
Secondary
Number of Participants Discontinued Due to Adverse Events
Number of participants with Discontinuations due to Adverse Events
Time frame: Through study completion (up to 132 Days)
Population: Safety Population - any participant that received at least one dose of study medication and had at least one safety assessment post-baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ibrexafungerp 750mg | Number of Participants Discontinued Due to Adverse Events | 1 Participants |
Secondary
Percentage of Participants Surviving 42 and 84 Days
Percentage of participants Surviving at Day 42 and Day 84 after Day 1 (first dose of study drug)
Time frame: Day 42 and Day 84 after first dose of study drug
Population: Intent to Treat Population (ITT): all subjects who were enrolled in the study
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ibrexafungerp 750mg | Percentage of Participants Surviving 42 and 84 Days | Day 42 | Survived | 24 Participants |
| Ibrexafungerp 750mg | Percentage of Participants Surviving 42 and 84 Days | Day 42 | Died | 4 Participants |
| Ibrexafungerp 750mg | Percentage of Participants Surviving 42 and 84 Days | Day 42 | Unknown survival status | 2 Participants |
| Ibrexafungerp 750mg | Percentage of Participants Surviving 42 and 84 Days | Day 84 | Survived | 19 Participants |
| Ibrexafungerp 750mg | Percentage of Participants Surviving 42 and 84 Days | Day 84 | Died | 8 Participants |
| Ibrexafungerp 750mg | Percentage of Participants Surviving 42 and 84 Days | Day 84 | Unknown survival status | 3 Participants |
Secondary
Percentage of Participants With Recurrence of Baseline Fungal Infection
The percentage of participants with a recurrence of the baseline fungal infection at the 6 week follow-up
Time frame: 42 Days after the End of Treatment visit
Population: Participants in the Intent to Treat Population with Global Success at End of Treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ibrexafungerp 750mg | Percentage of Participants With Recurrence of Baseline Fungal Infection | 1 Participants |
Secondary
Percent of Participants With Treatment-emergent Adverse Events
Percent of participants with treatment-emergent Adverse Events (TEAEs)
Time frame: Through study completion, up to 132 days
Population: Safety Population: any participant that received at least one dose of study medication and had at least one safety assessment post-baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ibrexafungerp 750mg | Percent of Participants With Treatment-emergent Adverse Events | 25 Participants |