Strong Ph III data on Intercept's OCA, but shares hit by side effect concerns

USA-based Intercept Pharmaceuticals (Nasdaq: ICPT) reported positive Phase III results on its obeticholic acid (OCA) on Sunday, but the company’s shares fell sharply on potential adverse effect in morning trading Monday.

Intercept announced that its international Phase III POISE trial of obeticholic acid for the treatment of primary biliary cirrhosis (PBC) demonstrated that OCA, at both a 10mg dose and a 5mg dose titrated to 10mg, met the trial's primary endpoint of achieving a reduction in serum alkaline phosphatase (ALP) to = 15% reduction from baseline and a normal bilirubin level after 12 months of therapy. The proportion of patients meeting the POISE primary endpoint was: 10% in the placebo group, 47% in the 10mg OCA group and 46% in the 5-10mg OCA group (both dose groups p

OCA, Intercept's lead product candidate, is a bile acid analog and first-in-class agonist of the farnesoid X receptor (FXR) in development for PBC, non-alcoholic steatohepatitis (NASH) and other liver and intestinal diseases.