Intercept initiates OCA FLINT trial in patients with nonalcoholic steatohepatitis
March 05, 2017
FLINT will enroll 280 patients at the eight U.S. centers comprising the NIDDK-sponsored NASH Clinical Research Network. The primary endpoint in the 72 week study will be determined by liver biopsy and is defined as an improvement in the NAFLD activity score with no worsening of liver fibrosis. NIDDK is providing the majority of funding for the study and is partnering with Intercept under a cooperative research and development agreement (CRADA).
"It is a privilege to be collaborating with this group of leading NASH investigators and the NIDDK," commented David Shapiro, MD, Chief Medical Officer of Intercept. "FLINT has been carefully designed to evaluate the efficacy of OCA in NASH patients and we believe it will be the largest clinical trial conducted to date in this large untreated patient population."
"Past clinical trials of marketed drugs in NASH have been disappointing and an effective therapy is urgently needed," added Mark Pruzanski, MD, Intercept's founder and CEO. "We believe that OCA's mechanism of action as an FXR agonist makes it a very promising candidate and we are excited that the FLINT study has started enrolling patients."
SOURCE Intercept Pharmaceuticals, Inc.