Intercept Announces Publication of Results from the Interim Analysis of the Phase 3 REGENERATE Study of OCA for the Treatment of Fibrosis Due to NASH in The Lancet

NEW YORK, Dec. 05, 2019 (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 the positive results from the interim analysis of the Phase 3 REGENERATE study of obeticholic acid (OCA) in patients with fibrosis due to nonalcoholic steatohepatitis (NASH) have been published in The Lancet. This is the first peer-reviewed publication of positive results from a pivotal study evaluating an investigational therapy for NASH.

“The first positive Phase 3 study results in NASH represent a real watershed moment for the hepatology field,” said Zobair M. Younossi, M.D., Professor and Chairman of the Department of Medicine at Inova Fairfax Medical Campus, Chair of the REGENERATE Steering Committee and a lead author of the publication. “The antifibrotic efficacy observed with just 18 months of OCA treatment in REGENERATE is particularly meaningful because fibrosis is the most important histological predictor of liver failure and death in patients with NASH.”

REGENERATE is an ongoing study that will continue through clinical outcomes for verification and description of clinical benefit. Data from the 18-month interim analysis of the study served as the basis for the New Drug Application (NDA) for OCA for the treatment of fibrosis due to NASH, which was accepted by the U.S. Food and Drug Administration (FDA) in November 2019. As previously announced, Intercept also plans to file a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the fourth quarter of 2019.

About Liver Fibrosis due to 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. Advanced fibrosis is associated with a substantially higher risk of liver-related morbidity and all-cause mortality in patients with NASH and, as early as 2020, the disease is projected to become the leading cause of liver transplants in the United States. There are currently no medications approved for the treatment of NASH.