Shares of Intercept Pharmaceuticals (NASDAQ:ICPT) are up 56% premarket on light volume after the company disclosed positive results in a clinical trial of its lead product candidate.
In a Phase 2b trial (10-Q, page 18), called FLINT, the safety and efficacy of obeticholic acid (OCA) was being evaluated for the treatment of nonalcoholic steatohepatitis (NASH). The U.S. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) sponsored the study.
NIDDK stopped the trial early after its planned interim analysis showed that OCA met its primary efficacy endpoint. The proportion of patients meeting the primary endpoint of a decrease in NAFLD Activity Score (NAS) of at least two points with no worsening of fibrosis was 46% in the OCA treatment arm versus 21% for placebo.