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Initiation of FLINT Announced by NIDDK: Study of Intercept Pharmaceuticals' Obeticholic Acid (INT-747) in NASH
Date:3/29/2011

fficer of Intercept. "FLINT has been carefully designed to evaluate the efficacy of OCA in NASH patients and we believe it will be the largest clinical trial conducted to date in this large untreated patient population."

"Past clinical trials of marketed drugs in NASH have been disappointing and an effective therapy is urgently needed," added Mark Pruzanski, MD, Intercept's founder and CEO. "We believe that OCA's mechanism of action as an FXR agonist makes it a very promising candidate and we are excited that the FLINT study has started enrolling patients."

See http://www.clinicaltrials.gov/ct2/show/NCT01265498?term=NCT01265498&rank=1 for additional information about FLINT.

About Obeticholic Acid (OCA or INT-747)

OCA is a potent, first-in-class farnesoid X receptor (FXR) agonist derived from the primary human bile acid chenodeoxycholic acid, the natural endogenous FXR agonist.  Intercept has announced positive Phase II results from randomized clinical trials in type 2 diabetics with NAFLD and in patients with primary biliary cirrhosis (PBC), the most common autoimmune liver disease.  These clinical data and OCA's mechanism of action support its potential as a novel, hepatoprotective agent in a broad range of chronic liver diseases. Intercept is currently preparing for the initiation of a Phase III PBC program in the U.S. and Europe, while pursuing additional studies in other indications such as NASH and portal hypertension.  

About Intercept Pharmaceuticals

Intercept is a biopharmaceutical company focused on discovering and developing small molecule drugs for the treatment of chronic liver and metabolic diseases.  The company's most advanced programs are focused on the development of modified bile acids that are selective for FXR, a nuclear receptor, and TGR5, a G protein-coupled receptor. Bil
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SOURCE Intercept Pharmaceuticals, Inc.
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