Success for obeticholic acid in Phase III POISE study for Primary Biliary Cirrhosis - Intercept Pharma

Intercept Pharmaceuticals, Inc. announced that its international Phase III POISE trial of obeticholic acid (OCA) for the treatment of Primary Biliary Cirrhosis (PBC) emonstrated 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 (ALP) to < 1.67x ULN with at least 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 10 mg OCA group and 46% in the 5-10 mg OCA group (both dose groups p < 0.0001 vs placebo) 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 (both dose groups p < 0.0001 vs placebo). In addition, both OCA dose groups met pre-specified secondary endpoints of improvements in other liver function parameters, including GGT, ALT, AST and total bilirubin (both dose groups p < 0.0005 vs placebo).