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 plus DAB refers to the investigational antifungal SCY-078, also known as ibrexafungerp, studied in combination with another agent for treating fungal infections. It is being developed by SCYNEXIS, Inc. (ticker: SCYX) and has been evaluated in clinical trials for conditions including vulvovaginal candidiasis and invasive candidiasis.
SCY-078 plus DAB has been studied for the treatment of Candida vulvovaginitis, vulvovaginal candidiasis, invasive candidiasis, and other mycoses. These are fungal infections caused by Candida species, including some resistant strains. The combination is not approved and remains investigational.
SCY-078 plus DAB is being developed by SCYNEXIS, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol SCYX. SCYNEXIS is responsible for the clinical development of SCY-078 and its combination regimens.
SCY-078 plus DAB is in Phase 2 clinical development. The Phase 2 trials have been completed, and the drug is not yet approved for any indication. It remains an investigational therapy.
SCY-078 plus DAB has been evaluated in several completed clinical trials, including NCT03363841 (Phase 3, invasive candidiasis caused by Candida auris), NCT03253094 (Phase 2, acute vulvovaginal candidiasis), NCT02679456 (Phase 2, vulvovaginal candidiasis), and NCT02244606 (Phase 2, invasive candidiasis). All trials are completed.