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Intercept Pharmaceuticals Announces Positive Phase II Results for INT-747 as a Treatment for Primary Biliary Cirrhosis
Date:10/27/2009

Phase II study results in type 2 diabetes patients with nonalcoholic fatty liver disease, supports INT-747's potential as a novel therapeutic across a range of chronic liver diseases. We intend to present the complete data set from the study at an appropriate scientific meeting in 2010."

Intercept's Chief Medical Officer, David Shapiro, MD, commented, "This study involved more than 30 centers in eight countries and has given us a better understanding of the needs of PBC patients, as well as a good working relationship with the hepatologists looking after them across North America and Europe. With this PBC network in place, we are well positioned to conduct a Phase III program. We intend to request an End of Phase II Meeting with FDA to review the results and plans for a Phase III program."

About INT-747 (first-in-class FXR agonist)

INT-747 is a potent, first-in-class farnesoid X receptor (FXR) agonist derived from the primary human bile acid chenodeoxycholic acid (CDCA), the natural endogenous FXR agonist. INT-747 is formulated as an orally bioavailable drug given once daily. Bile acid signaling through FXR has been shown to regulate the regenerative properties of the liver and, in numerous animal models of liver disease, INT-747 treatment prevents, and even reverses, liver damage caused by progressive fibrosis (scarring). FXR is also expressed in the intestine and kidney and INT-747 exhibits similar protective antifibrotic effects in models of inflammatory bowel disease and diabetic nephropathy.

About Intercept Pharmaceuticals

Intercept is a clinical stage biopharmaceutical company focused on discovering and developing small molecule drugs for the treatment of chronic fibrotic 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. Intercept's le
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SOURCE Intercept Pharmaceuticals, Inc.
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