Intercept Shares Skyrocket After Liver Drug Nails Mid-Stage Study

1/9/14Follow @benthefidler

Those that invested in the Intercept Pharmaceuticals (NASDAQ: ICPT) IPO last year are likely dancing in the streets today.

The New York-based biotech’s shares soared more than 230 percent—from a $72.39 Wednesday close to $239.02—in pre-market trading. Investors are clamoring into the stock after Intercept announced that it stopped a mid-stage clinical trial early because the drug showed such an obvious benefit for liver patients. The drug, obeticholic acid (OCA), is being developed for nonalcoholic steatohepatitis (NASH), a leading cause of cirrhosis and liver failure.

The Phase IIb clinical trial, sponsored by the National Institutes of Health, was halted after an independent data safety monitoring board looked at liver biopsy data of about half of the 283 patients in the study before and after treatment and found a “highly statistically significant improvement” in their condition. The positive news from the study, known as FLINT, shocked even Intercept executives.

“The unexpected early stopping of FLINT due to OCA meeting the primary endpoint with such high significance is a major milestone,” said Intercept CEO Mark Pruzanski, in a statement.

Nonalcoholic steateohepatitis, or NASH, is a condition in which fat builds up in the liver, leading to chronic inflammation and scarring that can ultimately cause cirrhosis and liver failure. It’s seen in people with diets high in fat and sugar. About 12 percent of the U.S. population has NASH, according to studies cited by Intercept.

Intercept’s drug, meanwhile, targets what’s known as a farnesoid X receptor, which is found in high concentration in the liver and intestine. Intercept is testing the drug in patients with other rare forms of chronic liver disease like primary biliary cirrhosis. Intercept owns most of the rights to the drug. Dainippon Sumitomo holds rights to Intercept’s drug in Japan and China.

Intercept went public last year at $15 per share.

Ben Fidler is Xconomy's Deputy Biotechnology Editor. You can e-mail him at bfidler@xconomy.com Follow @benthefidler

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