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Intercept Pharmaceuticals to Collaborate With NIDDK on Study of Obeticholic Acid (INT-747) in Nonalcoholic Steatohepatitis (NASH)
Date:7/28/2010

Mark Pruzanski, MD, founder, President and CEO of Intercept, commented, "We are excited to collaborate with the NIDDK and CRN to test our drug in such a robust NASH study.  Last year we presented data showing that obeticholic acid improved insulin sensitivity, lowered liver enzymes and induced weight loss in type 2 diabetic patients with NAFLD. These results and the novel mechanism of action of our drug are a promising basis for pursuing NASH."  

Pat Robuck, PhD, MPH, the senior advisor for clinical trials in digestive and liver diseases, in the NIDDK's Division of Digestive Diseases and Nutrition, stated, "There is a huge unmet medical need in this patient population. The NIDDK, working together with our NASH CRN investigators, is committed to discovering effective and safe treatments for this serious disease.  The preclinical and clinical data obtained so far with obeticholic acid suggest that it has beneficial effects on glucose metabolism and the liver, and the NASH CRN steering committee thinks it warrants rigorous clinical evaluation in NASH."

About Obeticholic Acid (INT-747)

Obeticholic acid 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.  Previously known as INT-747, the drug was recently given the generic name of obeticholic acid.  In 2009, the company announced two sets of positive Phase II results from studies in type 2 diabetics with NAFLD and in patients with refractory primary biliary cirrhosis (PBC). These data support obeticholic acid's potential as a novel, hepatoprotective agent in a broad range of chronic liver diseases. Intercept currently plans to advance obeticholic acid into Phase III for PBC, while pursuing addition
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SOURCE Intercept Pharmaceuticals, Inc.
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