Intercept: Phase 3 Study of Obeticholic Acid in Compensated Cirrhosis due to NASH Missed Primary Endpoint

 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 REVERSE, a Phase 3 study evaluating the safety and efficacy of OCA in patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH), did not meet its primary endpoint of a ≥ 1-stage histological improvement in fibrosis with no worsening of NASH following up to 18 months of therapy. No new safety signals for OCA were observed in this population of patients with cirrhosis.

REVERSE is one of Intercept’s two Phase 3 studies evaluating different populations in NASH. The Company’s planned NDA for its lead indication of liver fibrosis due to NASH will be supported by positive Phase 3 data from the REGENERATE study and is unaffected by the efficacy results of REVERSE. The Company is on track to resubmit its NDA in liver fibrosis due to NASH by the end of the year.

https://www.biospace.com/article/releases/ceuticals-announces-reverse-phase-3-study-of-obeticholic-acid-oca-in-compensated-cirrhosis-due-to-nash-did-not-meet-its-primary-endpoint/