Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SCY-635 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks |
| SCY-635 600 mg | ACTIVE_COMPARATOR | SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks |
| Placebo comparator | PLACEBO_COMPARATOR | - |
| SCY-635 30 mg once daily | ACTIVE_COMPARATOR | - |
| SCY-635 100 mg once daily | ACTIVE_COMPARATOR | - |
| SCY-635 300 mg once daily | ACTIVE_COMPARATOR | - |
| SCY-635 100 mg three times daily | ACTIVE_COMPARATOR | - |
| SCY-635 200 mg three times daily | ACTIVE_COMPARATOR | - |
| SCY-635 300 mg three times daily | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Oral tablets given bid for 28 days |
| SCY-635 | DRUG | SCY-635 tablets, 300 mg bid for 28 days |
| Pegasys | DRUG | 180 ug prefilled syringe given once per week for up to 48 weeks |
| Copegus | DRUG | tablets given bid for up to 48 weeks |
Inclusion Criteria: * Quantifiable serum levels of HCV-specific RNA in excess of 100,000 IU/mL * Chronic HCV status * HCV genotype 1 infection and IL28B genotype of C/T or T/T * Liver biopsy results within 3 years prior to screening indicating the absence of cirrhosis \*If no previous biopsy is ...
SCY-635 is an investigational small molecule being studied for the treatment of chronic hepatitis C and hepatitis C infection. It has been evaluated in clinical trials as a potential therapy for patients with hepatitis C, but it is not approved for any indication and remains in clinical development.
SCY-635 targets cyclophilin A, also known as PPIA (peptidylprolyl isomerase A). It acts as an inhibitor of this protein. By inhibiting PPIA, SCY-635 interferes with the hepatitis C virus life cycle, which is the basis for its investigation as an antiviral treatment for chronic hepatitis C.
SCY-635 is being developed by SCYNEXIS, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol SCYX. SCYNEXIS is the sponsor of the clinical trials evaluating SCY-635 in patients with hepatitis C.
SCY-635 is in Phase 1 clinical development. It has completed a Phase 1 trial and a Phase 2 trial, but it is not FDA approved and remains an investigational drug. No active trials are currently listed for SCY-635.
SCY-635 has been studied in two completed clinical trials: NCT01290965, a Phase 1 trial titled 'Safety, PK and Efficacy of 15 Days of SCY-635 Treatment in Hepatitis C Patients' with 57 participants, and NCT01265511, a Phase 2 trial titled 'Study of SCY-635, Pegasys and Copegus in Hepatitis C' with 10 participants.