Intercept Pharma Announces Positive Pivotal Phase 3 POISE Trial Results

(RTTNews) - Intercept Pharmaceuticals, Inc. (ICPT) announced that its international Phase 3 POISE trial of obeticholic acid or OCA for the treatment of primary biliary cirrhosis or PBC demonstrated that OCA, at both a 10 mg dose and a 5 mg dose titrated to 10 mg, met the trial's primary endpoint of achieving a reduction in serum alkaline phosphatase or ALP to reduction from baseline and a normal bilirubin level after 12 months of therapy.

The company noted that the proportion of patients meeting the POISE primary endpoint was 10% in the placebo group, 47% in the 10 mg OCA group and 46% in the 5-10 mg OCA group in an intention to treat analysis. The placebo group experienced a mean decrease in ALP from baseline of 5%, compared to a significant mean decrease of 39% in the 10 mg OCA dose group and 33% in the 5-10 mg OCA titration group.

Intercept stated that both OCA dose groups met pre-specified secondary endpoints of improvements in other liver function parameters, including GGT, ALT, AST and total bilirubin.