Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDP-494 · 1 trial · 1 indication
Tabulation of the number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, echo and abnormal clinical laboratory results (including chemistry, hematology, and urine). Administered to healthy volunteers and multiple doses of EDP-494 administered to healthy volunteers and subjects with Chronic Hepatitis C (CHC) genotype 1 and 3 infection
| Arm | Type | Description |
|---|---|---|
| EDP-494 SAD Cohorts | EXPERIMENTAL | EDP-494, oral 50 mg, 100mg, 200mg, 400mg and 800 mg, capsules, once daily in one single administration |
| EDP-494 MAD/POC Cohorts | EXPERIMENTAL | EDP-494, oral 200mg, 400mg and 800 mg, capsules, once daily for 14 days |
| EDP-494 SAD Placebo Cohort | PLACEBO_COMPARATOR | - |
| EDP-494 MAD/POC Placebo Cohort | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| EDP-494 | DRUG | 10, 100 and 200 mg capsules |
| Placebo | DRUG | placebo to match EDP-494 |
Inclusion Criteria for Healthy Volunteers (SAD and MAD Phases): * Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive. * Female subjects must be of non-childbearing potential. * All male participants who have not had a vasectomy must use effective co...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir |
EDP-494 is an investigational small molecule antiviral developed by Enanta Pharmaceuticals for the treatment of hepatitis C. It is a cyclophilin inhibitor that has completed a Phase 1 clinical trial. EDP-494 has not been approved by the FDA and remains in clinical development.
EDP-494 is being developed as a treatment for hepatitis C virus infection. It is a small molecule cyclophilin inhibitor. The drug has been studied in a Phase 1 trial that enrolled healthy subjects and hepatitis C patients. It is not yet approved for any indication.
EDP-494 targets cyclophilin, a host protein involved in hepatitis C virus replication. By inhibiting cyclophilin, EDP-494 is designed to interfere with the viral life cycle. This mechanism is distinct from direct-acting antivirals that target viral proteins.
EDP-494 is being developed by Enanta Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol ENTA. Enanta is a biotechnology company focused on small molecule drugs for viral infections and other diseases.
EDP-494 is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently in active trials. The drug is investigational and has not received FDA approval for any indication.
EDP-494 has been evaluated in a single completed Phase 1 trial, NCT02652377, titled EDP-494-001: A Study of EDP-494 in Healthy Subjects and Hepatitis C Patients. The trial enrolled 100 participants in New Zealand and was randomized, double-blind, and placebo-controlled.