Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]-Ibrexafungerp
Ibrexafungerp · 8 trials · 16 indications
Percentage of participants with complete resolution of signs and symptoms (total VSS score of 0) with no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.
Efficacy as measured by the percentage of subjects with documented Clinical Success.
The percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
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.
To determine the levels of SCY-078 in breast milk in ng/mL, starting pre-dose (Baseline) on Day 1 until 108 hours post first dose. Concentrations of SCY-078 in milk is measured pre-dose, and in milk collected at the following post-dose intervals: 0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, 18-24 hours, 24-36 hours, 36-48 hours, 48-72 hours and 72-108 hours.
To measure the levels of SCY-078 in plasma at pre-dose (0 hours), 2, 6, 8 12 hours post dose (prior to the second dose) and 24, 36, 48, 72 and 108 hours post first dose.
Mass balance recovery of total radioactivity in urine, faeces and all excreta (urine and faeces): cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae)
Determination of primary metabolites using liquid chromatography-radio-detection
Area under the plasma concentration versus time curve (AUC) will be estimated where possible
Area under the plasma concentration versus time curve (AUC) of total radioactivity in blood where possible
Peak Plasma Concentration (Cmax) of Ibrexafungerp will be estimated
Amount recovered expressed as a percentage of the dose administered
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Subjects without underlying medical conditions and have isolates other than C glabrata, C krusei, C auris. Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day. |
| Group B (3 Day dosing) | EXPERIMENTAL | Subjects with underlying medical conditions: DM, immunocompromised conditions (e.g. HIV), debilitation, immunosuppressive therapy (e.g. corticosteroids), recurrent VVC (≥3 episodes/year) and/or known to have C glabrata, C krusei or C auris isolates. Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day. |
| Group B (7 Day dosing) | EXPERIMENTAL | Subjects with underlying medical conditions: DM, immunocompromised conditions (e.g. HIV), debilitation, immunosuppressive therapy (e.g. corticosteroids), recurrent VVC (≥3 episodes/year) and/or known to have C glabrata, C krusei or C auris isolates. Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day |
| Ibrexafungerp | EXPERIMENTAL | Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Ibrexafungerp 300 mg BID (one day) every 4 weeks for a total of 6 dosing days |
| Placebo | PLACEBO_COMPARATOR | Oral Fluconazole 150 mg every 72 hours for 3 doses followed by Oral Placebo BID (one day) every 4 weeks for a total of 6 dosing days |
| Ibrexafungerp (SCY-078) | EXPERIMENTAL | 300 mg BID for one day |
| Open Label Treatment | OTHER | Participants received a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H) |
| Single dose of [14^C]-Ibrexafungerp | EXPERIMENTAL | Each subject will receive a dose of \[14C\]-Ibrexafungerp at 12 h intervals for 7 doses in total. |
| Name | Type | Description |
|---|---|---|
| Ibrexafungerp | DRUG | Each day dosing will consist of two 150mg tablets taken BID. |
| Fluconazole Tablet | DRUG | 150 mg every 72 hours for 3 doses |
| Placebo oral tablet | DRUG | BID (one day) every 4 weeks for a total of 6 dosing days |
| Placebo | DRUG | Matching Placebo |
| [14C]-Ibrexafungerp | DRUG | Radio-labeled Ibrexafungerp, single dose. |
Inclusion Criteria: 1. Subject is a post menarchal female ≥18 years of age at the time of signing the ICF. 2. Subject has a diagnosis of symptomatic VVC that meets the following criteria at the Screening visit: 1. Minimum composite vulvovaginal signs and symptoms score of ≥4 with at least 2 ...
Ibrexafungerp is an investigational small molecule being studied for fungal infections, including Candida vulvovaginitis, recurrent vulvovaginal candidiasis, complicated vulvovaginal candidiasis, and invasive candidiasis. It is in Phase 3 development in the infectious disease therapeutic area.
Ibrexafungerp is developed by SCYNEXIS, Inc., which trades under the ticker SCYX. The company is the sponsor behind the clinical program evaluating the drug across vulvovaginal candidiasis and other fungal infection indications.
Ibrexafungerp is in Phase 3 clinical development. Its Phase 3 program includes a completed trial in complicated vulvovaginal candidiasis, alongside completed Phase 1 pharmacokinetic and absorption studies. The drug remains investigational and has not been established as approved.
Ibrexafungerp has been studied in completed trials including NCT05399641, a Phase 3 trial in complicated vulvovaginal candidiasis enrolling 150 women, NCT06954493, a Phase 1 pharmacokinetic study in healthy lactating women, and the Phase 1 ADME studies NCT05668429 and NCT04307082 in healthy male subjects.
Yes. [14C]-Ibrexafungerp is a radiolabeled form of ibrexafungerp used in absorption, distribution, metabolism, and excretion studies. Trials NCT05668429 and NCT04307082 used this carbon-14 labeled version to trace how the drug moves through and is cleared from the body in healthy male subjects.
Ibrexafungerp trials have been randomized, double-blind, and placebo-controlled, with total enrollment of 831 participants across the program. Studies span Phase 1 pharmacokinetic and ADME work in healthy volunteers and Phase 3 evaluation in patients with vulvovaginal candidiasis, conducted in the United States and United Kingdom.