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Additional Results of Global Primary Biliary Cirrhosis Study Group Analysis to be Presented at AASLD Annual Meeting
Date:10/1/2013

ugh the AASLD website, www.aasld.org.

Primary Biliary Cirrhosis and the Global PBC Study Group
PBC is an autoimmune chronic liver disease that typically affects women. The disease progresses in those patients who have an inadequate response to therapy and may require a liver transplant or die. Biochemical assessments of liver function, particularly by measuring plasma levels of ALP and bilirubin, are typically used by physicians to diagnose and manage PBC patients.  There is a log-linear relationship between ALP levels and transplant-free survival; higher levels are associated with a worse prognosis. Accordingly, the relationship between these biochemical assessments of liver function and adverse clinical outcomes is highly important in the selection of appropriate endpoints in therapeutic clinical trials.

Data from the Global PBC Study Group are being analyzed under the direction of Dr. Bettina Hansen, Dr. Henk van Buuren and colleagues at Erasmus University Medical Centre in Rotterdam, The Netherlands. Intercept is sponsoring this independent academic research program but is not involved in the data collection and analysis. In April 2013, the Global PBC Study Group presented an analysis of data from over 2,100 patients at the annual meeting of the European Association for the Study of the Liver (EASL).  These preliminary data demonstrated that the primary endpoint being used in Intercept's Phase 3 POISE trial is highly statistically predictive of liver transplant-free survival in PBC patients.   

About Intercept 
Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat orphan and more prevalent liver diseases utilizing its expertise in bile acid chemistry. The company's lead product candidate, obeticholic acid (OCA), is a bile ac
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SOURCE Intercept Pharmaceuticals
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