Obeticholic acid: Additional Phase IIa data

Additional data from the cohort of 10 patients with PBAD in the open-label, U.K. Phase IIa OBADIAH trial in patients with bile acid diarrhea showed that once-daily 25 mg obeticholic acid for 15 days significantly increased median fasting FGF19 levels, the primary endpoint, to 237 pg/mL at week 2 from 133 pg/mL at baseline (p=0.007). Intercept said "most" patients achieved a >60% increase in FGF19, which is a hormone that directly regulates bile acid synthesis in the liver according to the company. Additionally, obeticholic acid significantly reduced median stool frequency from 23 per week at baseline to 14 per week at week 2 (p=0.03) and significantly improved median Bristol Stool Form Scale assessing stool type score from 5.15 points at baseline to 4.34 points at week 2 (p=0.05). Intercept said stool frequency returned to pre-treatment baseline values during the 2 week follow-up period after stopping obeticholic acid treatment. Obeticholic acid was well tolerated. Data were presented at the Digestive Disease Week meeting in Orlando.

The trial, which is being conducted by researchers at Imperial College of London, is slated to complete enrollment of about 30 patients in mid-2013, with final data from all 3 cohorts expected in 2H13. The study population will consist of 3 groups - patients with PBAD, patients with secondary bile acid diarrhea due to Crohn's disease (CD) and a control population of patients with chronic diarrhea but with normal bile acid retention. In March, Intercept reported top-line data from the PBAD cohort (see BioCentury, April 1). ...