Intercept Pharmaceuticals, a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, announced the REVERSE trial (Randomized phase 3 Study Evaluating the Efficacy and Safety of Obeticholic Acid in 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.
“NASH is poised to soon eclipse hepatitis C as the leading reason for liver transplants in the US and Europe, so there is an urgent need for effective therapies that can reverse fibrosis and cirrhosis,” said Mark Pruzanski, M.D., president and chief executive officer of Intercept. “OCA is currently the only FDA-designated Breakthrough Therapy in development for NASH and, with our phase 3 trials REGENERATE and REVERSE underway, we are on track to bring the first approved therapy to NASH patients with fibrosis and cirrhosis who are at greatest risk of liver failure.”
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 US 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.