Obeticholic acid: Additional Phase II data
On Jan. 10, NIH's National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) reported additional data from the double-blind, U.S. Phase II FLINT trial in 283 patients with NASH showing that lipid abnormalities involving increased total cholesterol and LDL-C and reduced HDL-C were seen in patients who received Intercept's obeticholic acid compared to placebo. On Jan. 9, FLINT was stopped early on the recommendation of a DSMB after a planned interim analysis of about half of the randomized patients showed that once-daily 25 mg obeticholic acid for 72 weeks met the primary endpoint of a reduction in NAFLD activity score of >=2 points with no worsening of fibrosis vs. placebo (p=0.0024) (see BioCentury, Jan. 13).
NIDDK, which sponsored and conducted the trial, did not provide details on the magnitude of the lipid changes. 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 NAFLD. In 64 patients in the NAFLD trial, once-daily 25 mg obeticholic acid 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. ...