Intercept Provides Additional Information Regarding FLINT Trial

(RTTNews) - Intercept Pharmaceuticals, Inc. (ICPT) provided additional information regarding the FLINT clinical trial of obeticholic acid, or OCA, in nonalcoholic steatohepatitis, or NASH, based on a written statement by the National Institute of Diabetes & Digestive & Kidney Diseases, a part of the National Institutes of Health.

The NIDDK confirmed in its statement that: its decision to halt the 72-week therapeutic phase of FLINT was based on interim efficacy results showing that "OCA has a significant beneficial effect on liver damage due to NASH."; as specified in the protocol, a 24-week follow up period is now commencing and all FLINT patients will stop taking OCA or placebo no later than January 20, 2014; both the FLINT investigators and patients enrolled in the trial will remain blinded until completion of the follow up phase; all the trial data will then be thoroughly analyzed and the NIDDK anticipates presenting the results in the fourth quarter of 2014; lipid abnormalities involving increased total cholesterol and LDL and decreased HDL were seen in OCA-treated patients compared to placebo; since lipid abnormalities are common in NASH, all of the patients will be followed for the 24-week period to help determine whether lipids return to pre-treatment levels.

Intercept said, while the NIDDK did not provide any information concerning the magnitude of lipid effects, the company believes that the reported lipid changes in FLINT patients on OCA will likely be similar to the results previously reported in a clinical trial of OCA in diabetic patients with nonalcoholic fatty liver disease that were presented at the 2009 meeting of the American Association for the Study of Liver Disease by Dr. Arun Sanyal and subsequently described in a paper published in the journal Gastroenterology in 2013.