Intercept's OCA gets breakthrough designation in NASH

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) gained $49.31 (29%) to $220 in after hours-trading on Thursday after it said FDA granted breakthrough therapy designation to its OCA obeticholic acid ( DSP-1747) to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis.

Intercept said the designation was based on data from two Phase II trials of the oral farnesoid X receptor (FXR; NR1H4) agonist in NASH and non-alcoholic fatty liver disease (NAFLD). In the 283-patient FLINT trial, 45% of NASH patients given OCA had improved liver histology at 72 weeks vs. 21% of patients given placebo (p=0.0002). Intercept said the second trial, in 64 NAFLD patients, assessed the effect of OCA treatment on insulin sensitivity (see BioCentury Extra, Nov. 7, 2014). ...