Intercept has two ongoing Phase 2 studies, 747-213 and 747-214, that are designed to explore a range of therapeutic doses for the combination of OCA and bezafibrate. Study 747-213 is for patients outside of the United States. Study 747-214 is for patients in the United States.
The Phase 2a FRESH (FXR Effect on Severe Alcohol-Associated Hepatitis) study is a randomized, double-blind, dose-escalation study that is expected to enroll approximately 50 patients with saH across multiple clinical sites in the U.S., UK and France. The study aims to demonstrate and provide rationale for the selection of optimal dose(s) of INT-787 in the target patient population.
Investigational uses and have not been approved by the FDA or any other worldwide regulatory agency. Safety and efficacy have not been established.