PRESS RELEASE April 11, 2014, 9:07 a.m. ET
- Study Presented at EASL 2014 Named Best Oral Abstract in Basic Science at Annual Meeting -
- OCA Treatment Associated with Beneficial Decrease in Bacterial Translocation and Intestinal Permeability in an Experimental Animal Model of Cholestatic Liver Disease -
NEW YORK, April 11, 2014 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (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(TM) 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.
Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat orphan and more prevalent liver and intestinal diseases utilizing its expertise in bile acid chemistry. The company's lead product candidate, OCA, is a bile acid analog and first-in-class agonist of FXR. OCA is being developed for a variety of chronic liver diseases and patient populations including PBC, NASH, cirrhosis, portal hypertension, alcoholic hepatitis, primary sclerosing cholangitis (PSC) and bile acid diarrhea. OCA has received orphan drug designation in both the United States and Europe for the treatment of PBC and PSC. Intercept owns worldwide rights to OCA outside of Japan and China, where it has out-licensed the product candidate to Dainippon Sumitomo Pharma. For more information about Intercept, please visit the Company's website at: www.interceptpharma.com.
Safe Harbor Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, pre-clinical, clinical and regulatory developments for OCA; the implications of results of experimental data in animal models on the potential therapeutic benefit in patients; and our strategic directives under the caption "About Intercept." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of important risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the initiation, cost, timing, progress and results of Intercept's development activities, preclinical studies and clinical trials; the timing of and Intercept's ability to obtain and maintain regulatory approval of OCA, INT-767 and any other product candidates it may develop, particularly the possibility that regulatory authorities may require clinical outcomes data (and not just results based on achievement of a surrogate endpoint) as a condition to any marketing approval for OCA, and any related restrictions, limitations, and/or warnings in the label of any approved product candidates; Intercept's plans to research, develop and commercialize its product candidates; the election by Intercept's collaborators to pursue research, development and commercialization activities; Intercept's ability to attract collaborators with development, regulatory and commercialization expertise; Intercept's ability to obtain and maintain intellectual property protection for its product candidates; Intercept's ability to successfully commercialize its product candidates; the size and growth of the markets for Intercept's product candidates and its ability to serve those markets; the rate and degree of market acceptance of any future products; the success of competing drugs that are or become available; regulatory developments in the United States and other countries; the performance of third-party suppliers and manufacturers; Intercept's need for and ability to obtain additional financing; Intercept's estimates regarding expenses, future revenues and capital requirements and the accuracy thereof; Intercept's ability to retain key scientific or management personnel; and other factors discussed under the heading "Risk Factors" contained in Intercept's annual report on Form 10-K for the year ended December 31, 2013 filed on March 14, 2014 as well as any updates to these risk factors filed from time to time in Intercept's other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intercept undertakes no duty to update this information unless required by law.