Intercept Issues Preclinical Data Showing OCA's Potential Role in Preventing Complications of Cirrhosis

Intercept Pharmaceuticals, Inc.

(Intercept) today announced results from a preclinical study demonstrating the potential protective effects of the Company's lead product candidate obeticholic acid (OCA) in an experimental model of liver disease. The study was presented orally during the opening session of the International Liver Congress™ 2014, the 49th Annual Meeting of the European Association for the Study of the Liver (EASL) in London. The study has also been selected as the best oral abstract in Basic Science at ILC 2014. In the study, OCA administration was shown to have protective effects on bacterial translocation from the ileum in an experimental rat model of cholestasis. The six animals receiving OCA treatment experienced significant reduction of bacteria in mesenteric lymph nodes and all but one of these remained free from bacterial infection in the abdominal cavity. In contrast, all six animals in the control group developed an abdominal infection. OCA treatment was additionally associated with normalized intestinal permeability, along with reduced inflammation of the lymph nodes and spleen. This study is the first to show OCA treatment limits bacterial translocation from the small intestine. In patients with liver cirrhosis, this phenomenon manifests as spontaneous bacterial peritonitis, an acute infection in the abdominal cavity that results in high rates of sepsis and mortality. "This study provides additional insight into the protective role of FXR in the gut-liver axis with potentially promising implications for the treatment of patients with advanced liver disease because bacterial translocation is known to be a key contributing factor in the pathogenesis and complications of cirrhosis," said Wim Laleman, M.D. Ph.D., Professor in the Department of Liver and Biliopancreatic Disorders, University Hospital Gasthuisberg, K.U. Leuven, Leuven, Belgium. "When coupled with the clinical results for OCA in PBC and NASH, I believe these data demonstrate that FXR agonism has considerable potential in the treatment of patients with a broad spectrum of liver disease." "This study's selection as part of the opening session and as best oral abstract in Basic Science at EASL shows that there is growing interest among hepatologists in FXR and its hepatoprotective properties," said David Shapiro, M.D., chief medical officer of Intercept. "We believe that this new layer of understanding of OCA's mechanism of action and potential therapeutic effects in cirrhosis complements the clinical data we have reported in cirrhotic patients with alcoholic liver disease." Several additional OCA presentations will occur at ILC 2014. Among the highlights is a late breaker presentation of results from the POISE clinical trial, the first Phase 3 trial in PBC in two decades. Intercept will be exhibiting at booth #715 throughout ILC 2014.