Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SCY-078
SCY-078 plus DAB · 4 trials · 5 indications
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.
Measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
Therapeutic Cure defined as achieving both a Clinical Cure (resolution of signs and symptoms) and a Mycological Eradication (negative culture).
All Related TEAEs by SOC and PT, by Treatment, Safety
Summary of PK Parameters on Day 1 by Treatment Arm, from non-compartmental analysis, PK
| Arm | Type | Description |
|---|---|---|
| SCY-078 | EXPERIMENTAL | SCY-078 |
| Fluconazole | ACTIVE_COMPARATOR | 150 mg/day for 1 day |
| Ibrexafungerp 750mg | EXPERIMENTAL | 750mg QD for 1 day only |
| Ibrexafungerp 300mg | EXPERIMENTAL | 300mg BID for 1 day only |
| Ibrexafungerp 450mg | EXPERIMENTAL | 450mg BID for 1 day only |
| Ibrexafungerp 150mg | EXPERIMENTAL | 150mg BID for 3 days |
| Ibrexafungerp 300mg D1-D3 | EXPERIMENTAL | 300mg BID for 3 days |
| Treatment Group 1 (Fluconazole) | ACTIVE_COMPARATOR | Fluconazole |
| Treatment Group 2: (SCY-078) | EXPERIMENTAL | Dose regimen 1 |
| Treatment Group 3 (SCY-078) | EXPERIMENTAL | Dose regimen 2 |
| SCY-078 500 mg | EXPERIMENTAL | A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days. |
| SCY-078 750 mg | EXPERIMENTAL | A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days. |
| Standard-of-care | ACTIVE_COMPARATOR | Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily. |
| Name | Type | Description |
|---|---|---|
| SCY-078 | DRUG | Oral SCY-078 |
| Fluconazole | DRUG | Oral Antifungal comparator |
| Micafungin | DRUG | - |
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 ...
SCY-078, also known as ibrexafungerp, is an investigational small molecule being studied for the treatment of fungal infections, including invasive candidiasis, candidemia, and vulvovaginal candidiasis. It is being developed by SCYNEXIS, Inc. (SCYX) and is currently in Phase 2 clinical development.
SCY-078 targets the fungal cell wall by inhibiting glucan synthase, an enzyme essential for the synthesis of beta-glucan. This mechanism disrupts fungal cell wall integrity, leading to cell death. The drug is being evaluated for its efficacy against Candida species, including Candida auris.
SCY-078 is being developed by SCYNEXIS, Inc., a biopharmaceutical company focused on developing innovative therapies for fungal infections. The company's stock ticker is SCYX. SCY-078 is also known by the name ibrexafungerp.
SCY-078 is in Phase 2 clinical development for the treatment of fungal infections. It is an investigational drug and has not yet been approved by regulatory authorities. Clinical trials have been completed for invasive candidiasis and vulvovaginal candidiasis, with ongoing research into its safety and efficacy.
SCY-078 has completed several clinical trials, including NCT02244606 for invasive candidiasis, NCT02679456 and NCT03253094 for vulvovaginal candidiasis, and NCT03363841 for candidiasis caused by Candida auris. These trials have evaluated the drug's safety and efficacy compared to standard treatments.
Yes, SCY-078 is the same as ibrexafungerp. The drug is referred to by both names in clinical research and development. SCYNEXIS, Inc. is developing ibrexafungerp (SCY-078) as an oral treatment for various fungal infections.