NEW YORK, Jan. 29, 2020 (GLOBE NEWSWIRE) — Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that it has completed patient enrollment in its Phase 3 REVERSE study evaluating obeticholic acid (OCA) for the treatment of compensated cirrhosis due to nonalcoholic steatohepatitis (NASH).
“NASH patients who develop cirrhosis have a significantly increased risk of liver failure and death,” said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. “The completion of enrollment in REVERSE brings us one step closer to bringing a much-needed therapy to the growing number of people living with compensated cirrhosis due to this disease.”The REVERSE study is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study evaluating the safety and efficacy of OCA in NASH patients with compensated cirrhosis. The primary endpoint is the percentage of patients with histological improvement in fibrosis by at least one stage with no worsening of NASH using the NASH Clinical Research Network (CRN) scoring system after 18 months of treatment. Over 900 patients have been randomized in a 1:1:1 ratio to the three treatment arms: once-daily OCA 10 mg, once-daily OCA 10 mg for the first three months with titration in accordance with the study protocol up to OCA 25 mg for the remaining study period, or once-daily 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.About Liver Fibrosis and Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)Nonalcoholic steatohepatitis (NASH) is a serious progressive liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death. There are currently no medications approved for the treatment of NASH.Cirrhosis may result in decompensated liver disease associated with complications of ascites, variceal bleeding and hepatic encephalopathy. Liver failure is believed to be the main cause of morbidity and mortality in patients with compensated cirrhosis due to NASH, and patients with cirrhosis are at 105 times greater risk of liver related morbidity compared to those without fibrosis. In addition, in the U.S. patients with cirrhosis are estimated to account for more than 80 percent of annual direct medical costs in NASH.About InterceptIntercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Founded in 2002 in New York, Intercept has operations in the United States, Europe and Canada. For more information, please visit www.interceptpharma.com or connect with the company on Twitter and LinkedIn.Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements, including, but not limited to, statements regarding the progress, timing and results of our clinical trials, including our clinical trials for the treatment of nonalcoholic steatohepatitis (“NASH”), the safety and efficacy of our approved product, Ocaliva (obeticholic acid or “OCA”) for primary biliary cholangitis (“PBC”), and our product development candidates, including OCA for NASH, the timing and acceptance of our regulatory filings and the potential approval of OCA for NASH or any other indications in addition to PBC, the timing and potential commercial success of OCA and any other product candidates we may develop and our strategy, future operations, future financial position, future revenue, projected costs, financial guidance, prospects, plans, and objectives.ContactFor more information about Intercept, please contact:Lisa DeFrancesco
+1-646-565-4833
[email protected]Christopher Frates
+1-646-757-2371
[email protected]
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