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New Analyses of the Phase 3 POISE Trial of Ocaliva™ (Obeticholic Acid) for the Treatment of PBC Presented at EASL

NEW YORK, April 14, 2016 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, today announced the results of two new analyses of the POISE trial, the Phase 3 trial of Ocaliva (obeticholic acid) for the treatment of primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC). The analyses, presented at the International Liver Congress 2016, the 51st Annual Meeting of the European Association for the Study of the Liver (EASL), examined a risk model to predict estimated liver transplant-free survival of patients in the POISE trial and assessed a titration strategy for managing treatment-related pruritus. Ocaliva is an investigational product and has not been granted marketing authorization or approval from any regulatory authority.

The effects of Ocaliva on patient outcomes in PBC have not been directly evaluated, but in the first analysis, researchers from Erasmus University Medical Center used a risk model developed by the Global PBC Study Group to predict liver transplant-free survival in patients treated with Ocaliva or placebo. Of 216 randomized patients in the POISE trial, 93% continued receiving ursodeoxycholic acid (UDCA), the current standard of care and only approved medication for PBC, upon initiating Ocaliva or placebo. The trial's primary endpoint was defined as a reduction in serum alkaline phosphatase (ALP) to below a threshold of 1.67 times upper limit normal, with a minimum of 15% reduction in ALP level from baseline, and a normal bilirubin level after 12 months of therapy. The Global PBC Study Group used data collected from more than 4,000 patients to construct and validate its risk model, with age at the beginning of UDCA therapy, total bilirubin, ALP, platelet count, and albumin following 12 months of treatment with UDCA identified as independent predictors of liver transplant-free survival. After one year, the model suggests patients treated with Ocaliva ±UDCA had significantly improved estimated liver transplant-free survival compared to the group treated with placebo ±UDCA (p<0.0001).

The second analysis utilizing the POISE study data examined the titration strategy used in the trial to address treatment-related pruritus. Pruritus is a common symptom of PBC and mild to moderate pruritus was the most common adverse event observed in POISE. The titration strategy – initiating Ocaliva at 5 mg and titrating up to 10 mg based on clinical response at six months – helped mitigate both the incidence and severity of pruritus, resulting in a single patient discontinuing Ocaliva in the titration group over 12 months of treatment. Despite an early increase at two weeks, patient-reported pruritus severity improved over the course of the study and by month six the Ocaliva 10 mg group and placebo ±UDCA group were similar. Additionally, titration appeared to delay time to onset in the subset of patients who experienced pruritus, with a median of 24 days in the...


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