Results of phase III REGENERATE study of Ocaliva in NASH published in The Lancet.- Intercept Pharma

Intercept Pharmaceuticals announced that the positive results from the interim analysis of the Phase III REGENERATE study of Ocaliva (obeticholic acid) 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. 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 FDA in November 2019. As previously announced, Intercept also plans to file a Marketing Authorization Application with the European Medicines Agency in the fourth quarter of 2019.

See: "Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial" Zobair M Younossi et al. The Lancet December 05, 2019DOI:https://doi.org/10.1016/S0140-6736(19)33041-7