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 developed for the treatment of Hepatitis C Infection and Chronic Hepatitis C. It is being studied in patients with these conditions, and clinical trials have been conducted in the United States and Puerto Rico.
SCY-635 is being developed by SCYNEXIS, Inc., a biopharmaceutical company traded on the stock exchange under the ticker SCYX. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug for hepatitis C.
SCY-635 is in clinical development. One completed study was a Phase 1 trial, and another completed study was a Phase 2 trial. The drug is investigational and has not been approved by regulatory authorities for commercial use.
SCY-635 has been studied in two completed clinical trials. NCT01290965 was a Phase 1 study of 15 days of SCY-635 treatment in 57 patients with Chronic Hepatitis C. NCT01265511 was a Phase 2 study combining SCY-635 with Pegasys and Copegus in 10 patients with Hepatitis C Infection.
SCY-635 is a distinct investigational small molecule. It has been studied in combination with Pegasys and Copegus, which are other hepatitis C treatments, but SCY-635 itself is a separate drug candidate being developed by SCYNEXIS, Inc.