Intercept announces new data analysis from FLINT trial of OCA
Intercept Pharmaceuticals announced a retrospective analysis of the Phase 2 FLINT trial in patients who had a diagnosis of nonalcoholic steatohepatitis, or NASH, and type 2 diabetes. The poster entitled "Improvements in Liver Histology with Obeticholic Acid in Patients with Nonalcoholic Steatohepatitis and Type 2 Diabetes Mellitus" was presented at the American Diabetes Association's 77th Scientific Sessions in San Diego, California. Obeticholic acid, or OCA, is an investigational therapy for the treatment of NASH. Both type 2 diabetes and advanced fibrosis are associated with lower transplant-free survival in patients with NASH. In FLINT, 149 NASH patients had type 2 diabetes and, within this population, 45% had advanced bridging fibrosis. In a retrospective analysis of FLINT patients with a diagnosis of NASH and type 2 diabetes at baseline, a greater percentage of OCA-treated patients achieved the primary endpoint of the trial, a greater than or equal to2-point improvement in NAFLD activity score, or NAS, without worsening of fibrosis, at week 72 as compared to placebo. More than twice as many OCA-treated patients with fibrosis experienced greater than or equal to1 stage of fibrosis improvement as compared to patients in the placebo group. This benefit was observed for every fibrosis stage. OCA treatment resulted in a mean 3.3 kg reduction in body weight from baseline compared to a 0.3 kg increase in the placebo group.