Intercept's Ocaliva meets in Phase II PSC trial

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) reported top-line data from the Phase II AESOP trial in 77 patients with primary sclerosing cholangitis (PSC) showing that once-daily 5 mg Ocaliva obeticholic acid (DSP-1747) titrated at week 12 to a 10 mg dose met the primary endpoint of reducing mean alkaline phosphatase levels from baseline to week 24 vs. placebo (reduction of 22% vs. increase of 1%, p<0.05). Once-daily 1.5 mg Ocaliva titrated at week 12 to a 3 mg dose also significantly reduced mean ALP levels from baseline to week 24 vs. placebo (reduction of 22% vs. increase of 1%, p<0.05). The most common adverse event reported was pruritus.

The double-blind, U.S. and Italian trial also evaluated safety. Secondary endpoints include hepatic biochemistry and fibrosis, gastrointestinal inflammation and disease, farnesoid X receptor (FXR; NR1H4) activity, inflammatory bowel disease (IBD), biomarkers and pharmacokinetics. About half of the patients in AESOP were receving ursodeoxycholic acid (UDCA) at baseline and continued on a stable dose during the trial. The study also includes a 2-year, open-label extension...