Intercept Pharma initiates REVERSE trial of obeticholic acid for patients with compensated cirrhosis due to NASH.

Intercept Pharmaceuticals announced the REVERSE trial ( Subjects with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis).REVERSE is a randomized, double-blind, placebo-controlled, multi-center study that will evaluate the efficacy and safety of the investigational therapy obeticholic acid (OCA) in approximately 540 patients with a biopsy-confirmed diagnosis of cirrhosis due to NASH. The REVERSE trial will be conducted at sites in North America, Europe, Australia and New Zealand.

The primary endpoint is the percentage of subjects with histological improvement in fibrosis by at least one stage using the NASH Clinical Research Network (CRN) scoring system after 12 months of treatment. Patients are being randomized in a 1:1:1 ratio to one of the three treatment arms: once-daily dosing of OCA 10 mg, once-daily OCA 10 mg with titration to 25 mg at three months, or placebo. Patients who successfully complete the double-blind phase of REVERSE will be eligible to enroll in an open-label extension phase for up to 12 additional months. Results from the double-blind phase of the study are intended to serve as the basis for seeking initial U.S. and international marketing authorizations of OCA for the treatment of NASH patients with compensated cirrhosis.

Consistent with regulatory requirements, a subsequent outcomes trial will be planned with the goal of confirming clinical benefit on a post-marketing basis in a broader population of NASH patients with cirrhosis.