Intercept Pharmaceuticals’ Phase III POISE trial meets primary endpoint

The pivotal Phase III POISE trial showed 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 < 1.67x ULN with a = 15% reduction from baseline and a normal bilirubin level after 12 months of therapy.

According to Intercept Pharmaceuticals, 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 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 10mg OCA dose group and 33% in the 5-10 mg OCA titration group.

Additionally, 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 vs placebo).

Intercept Pharmaceuticals chief medical officer Dr David Shapiro noted POISE is the company’s third successful international, placebo controlled trial of OCA in PBC patients conducted over the past seven years, setting the stage for its anticipated filing for approval of OCA in the US, Europe and other countries.

"With the results of POISE and our ongoing long-term study of PBC patients on therapy for more than four years, we have shown that OCA produces a significant durable response and believe this will result in better clinical outcomes for many patients.

"We would like to thank the many investigators and patients who participated in POISE and our other PBC trials," Dr Shapiro added.

Intercept Pharmaceuticals’ obeticholic acid is a bile acid analog and first-in-class agonist of the farnesoid X receptor in development for primary biliary cirrhosis, nonalcoholic steatohepatitis and other liver and intestinal diseases.