Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDP-297 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| EDP-297 SAD Cohorts | EXPERIMENTAL | EDP-297 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral solution, once daily in one single administration |
| EDP-297 MAD Cohorts | EXPERIMENTAL | EDP-297 Dose 1, Dose 2 and Dose 3 oral solution, once daily for 14 days |
| EDP-297 SAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, oral solution, once daily in one single administration |
| EDP-297 MAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, oral solution, once daily for 14 days |
| Name | Type | Description |
|---|---|---|
| EDP-297 | DRUG | EDP-297 Oral solution |
| Placebo | DRUG | placebo to match EDP-297 |
Inclusion Criteria: * An informed consent document signed and dated by the subject. * Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive. Exclusion Criteria: * Clinically relevant evidence or history of illness or disease. * Pregnant or nursing fe...
EDP-297 is an investigational small molecule developed by Enanta Pharmaceuticals, Inc. (ENTA) for NASH, or nonalcoholic steatohepatitis, with liver fibrosis. It is a Phase 1 clinical candidate and has not been approved by the FDA. NASH is a metabolic liver disease characterized by inflammation and fat accumulation that can progress to fibrosis.
EDP-297 is being developed for the treatment of NASH, or nonalcoholic steatohepatitis, with liver fibrosis. It is an investigational therapy and has not been approved for any indication. NASH with liver fibrosis is a progressive metabolic liver condition in which fat accumulation and inflammation lead to scarring of the liver.
EDP-297 targets FXR, the farnesoid X receptor. FXR is a nuclear receptor that regulates bile acid, lipid, and glucose metabolism, making it a relevant target in metabolic liver disease. EDP-297 is a small molecule designed to act on this receptor as part of its development for NASH with liver fibrosis.
EDP-297 is being developed by Enanta Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ENTA. Enanta is the sponsor of the clinical program evaluating EDP-297 in NASH with liver fibrosis.
EDP-297 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The completed Phase 1 study enrolled 82 participants and evaluated EDP-297 in healthy subjects, which is typical for early-stage safety and tolerability assessment.
EDP-297 has been evaluated in one completed Phase 1 trial, NCT04559126, titled A Study of EDP-297 in Healthy Subjects. The trial enrolled 82 participants in the Netherlands, was randomized, double-blind, and placebo-controlled, and included adults 18 years and older of all sexes.