NEW YORK, Nov. 12, 2012 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic liver diseases, has been informed by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health that patient enrollment in the FLINT trial has been completed. FLINT is a double blind, placebo controlled, multi-center Phase 2b clinical trial evaluating the treatment effects of OCA compared with placebo in adult nonalcoholic steatohepatitis (NASH) patients.
"We are thrilled that FLINT has completed enrollment as this is the largest NASH trial yet conducted. There are no approved therapies for NASH, the most prevalent liver disease in the developed world, and accordingly there is a very high medical need for treating these patients," said Mark Pruzanski, MD, Chief Executive Officer of Intercept.
FLINT has enrolled 280 patients at the eight U.S. centers comprising the NIDDK-sponsored NASH clinical research network. Patients have been randomized to receive either a 25mg dose of OCA or placebo. The primary endpoint in the 72-week trial will be evaluated by liver biopsy and is defined as an improvement in the NAFLD activity score with no worsening of liver fibrosis. NIDDK is providing the majority of funding for the trial and is partnering with Intercept under a cooperative research and development agreement. Further details can be found at http://clinicaltrial.gov/ct2/show/NCT01265498.
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 acid analog and first-in-class agonist of the farnesoid X receptor (FXR). OCA is initially being developed for the second line treatment of primary biliary cirrhosis (PBC) in patients with an inadequate response to, or who are unable to tolerate, ursodiol, the only approved therapy for this indication. PBC is a chronic autoimmune liver disease that may progress to cirrhosis and liver failure, and it is currently the fifth leading indication for liver transplant in the United States. OCA has orphan drug designation in both the United States and Europe for the treatment of PBC. Intercept owns worldwide rights to OCA outside of Japan and China, where it has outlicensed the product candidate to Dainippon Sumitomo Pharma (DSP). For more information about Intercept, please visit the Company's website at: www.interceptpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to OCA's potential to treat portal hypertension, the utility of the endpoints of the PESTO trial and Intercept's 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 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 success and timing of Intercept's preclinical studies and clinical trials; Intercept's ability to obtain and maintain regulatory approval of OCA and any other product candidates it may develop, and the labeling under any approval it may obtain; regulatory developments in the United States and other countries; the performance of third-party manufacturers; Intercept's plans to develop and commercialize its product candidates; Intercept's ability to obtain and maintain intellectual property protection for its product candidates; the successful development of Intercept's sales and marketing capabilities; the potential 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; the loss of key scientific or management personnel; Intercept's ability to obtain additional financing; the accuracy of Intercept's estimates regarding expenses, future revenues and capital requirements; and other factors discussed under the heading "Risk Factors" contained in Intercept's prospectus dated October 10, 2012 filed with the Securities and Exchange Commission pursuant to Rule 424(b) of the Securities Act of 1933, as amended, as well as any updates to these risk factors filed from time to time in Intercept's Quarterly Reports on Form 10-Q or Current Reports on Form 8-K and 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.
CONTACT: Mark Pruzanski, M.D., Barbara Duncan Intercept Pharmaceuticals 1-646-747-1000Source:Intercept Pharmaceuticals, Inc.