NASH companies fall on lipid data

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) fell $81.47 (18%) to $364.36 on Monday after NIH released data late Friday that showed lipid abnormalities in patients who received Intercept's obeticholic acid in the Phase II FLINT trial to treat non-alcoholic steatohepatitis (NASH). Last week, Intercept's shares skyrocketed after the company announced it stopped FLINT early after an interim analysis showed obeticholic acid met the primary endpoint in the trial. Despite Monday's drop, Intercept shares are still up more than 400% since last Wednesday, before the data were announced (see BioCentury, Jan. 13).

NIH's National Institute of Diabetes and Digestive and Kidney Diseases, which ran the FLINT trial, said patients who received obeticholic acid had increased total cholesterol and LDL-C and reduced HDL-C compared to patients who received placebo. NIDDK did not provide details on the magnitude of the incease. Intercept said it believes the lipid changes will likely be similar to the results from a previous Phase II trial of obeticholic acid to treat Type II diabetics with non-alcoholic fatty liver disease (NAFLD), in which the compound non-significantly increased total cholesterol (18 vs. 8 mg/dL, p=0.08) and significantly increased LDL-C (22 vs. 9 mg/dL, p=0.01) from baseline to day 43 vs. placebo. Intercept said it is conducting further studies to gain "a more complete understanding" of the clinical implications of the lipid changes. NIDDK said it expects to present data from the FLINT trial in 4Q14. ...