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April 12, 2014
20:04 EDTICPTIntercept reports additional positive data from POISE trial at EASL
Intercept Pharmaceuticals announced efficacy and safety results from the Phase 3 POISE trial of obeticholic acid, OCA, for the treatment of primary biliary cirrhosis, PBC, to be presented in a late-breaker session at the International Liver Congress of the European Association for the Study of the Liver, EASL. 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, nonalcoholic steatohepatitis, NASH, and other liver and intestinal diseases. As previously reported, the POISE trial met its primary endpoint with high statistical significance, demonstrating OCA's efficacy on a composite liver biochemical endpoint which has been shown to strongly correlate with improved clinical outcomes. 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. New data in the presentation show that OCA treated patients achieved a highly statistically significant reduction in alkaline phosphatase, ALP, as early as two weeks, with a peak effect achieved by six months.Pruritus, generally mild to moderate, was the most frequently reported adverse event in the POISE trial. However, only 1% of the patients in the OCA 5-10 mg titration group discontinued therapy due to pruritus after moving up to the 10 mg dose, as compared to seven, 10%, of the patients in the 10 mg OCA group. Additional data presented show that the incidence and severity of OCA related pruritus diminishes with time on therapy. Specifically, pruritus scores were no different from placebo in both OCA treatment groups during the second half of the trial.
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