Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) disclosed that REVERSE, a Phase 3 research investigating the safety and effectiveness of OCA in patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH), did not reach its main goal of a 1-stage histological improvement in fibrosis with no deterioration of NASH after up to 18 months of medication. In this cirrhotic patient cohort, no new safety signals for OCA were detected.

Intercept Pharmaceuticals, Inc. (ICPT) inches up to trade at $13.6 with the average traded volume of 1.14 million shares. The firm’s shares performance for the last one month was -19.69% and -8.46% in the previous week, whereas year to date performance was calculated -14.36%.

REVERSE is one of Intercept’s two Phase 3 trials assessing various NASH populations. The Company’s planned NDA for its main indication of NASH-related liver fibrosis will be supported by favorable Phase 3 data from the REGENERATE trial and will be unaffected by REVERSE efficacy results. The company is on pace to resubmit its NDA in NASH-related liver fibrosis before the end of the year.

“Achieving statistical significance on a histology endpoint in compensated cirrhosis due to NASH has proven to be an extremely high bar in clinical trials, emphasizing the importance of treating NASH-related liver fibrosis before it progresses to cirrhosis,” said M. Michelle Berrey, M.D., M.P.H., Intercept’s President of Research & Development and Chief Medical Officer. “We remain optimistic about the potential role of OCA in NASH-related liver fibrosis, and the Intercept team is working hard to resubmit our NDA in this indication based on the good Phase 3 REGENERATE data.”

Independent experts assessed specified categories of safety occurrences to give FDA with a blinded adjudication. These included hepatic safety, cardiovascular safety, and renal safety events. The number of adjudicated liver safety events for the OCA-treated arms increased numerically; the majority were low in severity and related to biochemical alterations. In any treatment arm, there were no severe or fatal adjudicated hepatic safety events. The frequency of adjudicated renal incidents and serious cardiac adverse events was equal across treatment groups.