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NEW YORK, Jan. 7, 2013 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel bile acid therapeutics to treat chronic liver diseases, today announced that its partner Dainippon Sumitomo Pharma (DSP) has initiated a phase 2 clinical trial of obeticholic acid (OCA) in adult nonalcoholic steatohepatitis (NASH) patients in Japan.
The trial is studying the efficacy and safety of a once daily dose of OCA, with the goal of randomizing 200 NASH patients to receiving OCA or placebo. The primary endpoint will be evaluated by histological improvement. DSP expects to complete the trial in the first half of 2016.
"We have previously shown that OCA can improve both liver enzyme levels and insulin sensitivity in diabetic patients with nonalcoholic fatty liver disease, so are pleased that we now have two randomized trials ongoing with OCA in NASH," commented Mark Pruzanski, MD, Intercept's Chief Executive Officer. "We recently announced that the NIDDK completed enrollment of FLINT, the U.S.-based phase 2b NASH trial from which we expect results in late 2014, and we are excited to see that DSP has moved quickly to start this trial after completing phase 1 studies with OCA in Japan."
NASH is a liver disease in which fat accumulates in the liver, inducing chronic inflammation and progressive fibrosis (scarring) that can lead to cirrhosis and liver failure. Studies have shown that at least 15% of NASH patients will develop liver cirrhosis over a ten to 15 year period. In the United States, the most recent epidemiological analysis concluded that more than 12% of the general population has NASH, while approximately 2.7%, or more than eight million patients, have advanced liver fibrosis or cirrhosis due to the disease. In the past decade, the proportion of liver transplants attributed to NASH increased from 1% to 10%, establishing NASH as the third leading indication for liver transplant in the United States. The prevalence of NASH in Europe and Japan is similar, and the disease has also become common in developing countries such as India and China. There are currently no drugs approved for the treatment of NASH.