Intercept Pharmaceuticals, Inc., announced the presentation of the results from its recently completed Phase II clinical trial of INT-747 (obeticholic acid) in patients with primary biliary cirrhosis (PBC). The oral presentation will take place during the Opening Session of the 45th Annual Meeting of the European Association for the Study of the Liver (EASL 2010) on April 15, 2010.

About the INT-747 Phase II Clinical Trial in Patients with PBC

This double blind, placebo controlled, dose response study evaluated INT-747's ability to lower serum alkaline phosphatase (AP) after 12 weeks of treatment in patients with an inadequate response to ursodeoxycholic acid (UDCA) treatment. AP is a validated marker of PBC disease progression and clinical outcome that is routinely used to evaluate the status of PBC patients and response to therapy. The study assessed the efficacy of INT-747 added to ongoing UDCA therapy in patients with AP values greater than or equal to 1.5x the upper limit of normal (ULN = 117 U/L). Other liver enzymes such as gamma glutamyl transferase (GGT) and alanine aminotransferase (ALT) general indicators of liver injury and function were also measured.

The study was conducted at more than 30 centers in eight countries across North America and Europe, the largest PBC study group assembled to date. 165 patients were randomized to one of three doses of INT-747 (10 mg, 25 mg or 50 mg) or placebo taken once daily for 12 weeks with a two-week follow up.

Highlights of the study results are as follows:

-- All three doses of INT-747 significantly lowered AP by 21-24.7% with absolute values decreasing by 66-77 U/L compared to a 2.6% (5 U/L) reduction in the placebo group (p