San Diego, CA — Conatus Pharmaceuticals Inc. CNAT, a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced the initiation of a Phase 2 clinical trial of its lead drug candidate, emricasan, in patients with nonalcoholic fatty liver disease (NAFLD), including the subset of NAFLD patients with inflammatory and/or fibrotic nonalcoholic steatohepatitis (NASH).
“Compelling preclinical data in models of both NAFLD and NASH suggest therapeutic potential for emricasan,” said Conatus Co-founder, President and Chief Executive Officer, Steven J. Mento, Ph.D., “and we believe that this trial is an important first step to evaluate that potential. Our goal for this trial is to expand our safety database into a broader patient population and to explore emricasan’s potential activity in the NAFLD/NASH population. Clinical endpoints suitable to support approval of new treatments for NASH have not yet been fully defined, and we are appropriately engaged in the ongoing discussions.”
The double-blind, placebo-controlled trial is designed to enroll approximately 40 patients at four planned U.S. clinical sites. Patients will be randomized 1:1 to receive either 25 mg of emricasan or placebo orally twice daily for 28 days and will then be followed for another 28 days. The primary endpoint in this exploratory proof-of-concept trial is a reduction of elevated levels of key biomarkers implicated in patients with NAFLD/NASH. The trial will also evaluate the safety and tolerability of emricasan in the target patient population. Top-line results are expected in the second half of 2014.
“We are pleased that we were able to accelerate initiation of our Phase 2 NAFLD/NASH trial,” added Dr. Mento, “consistent with our strategy of positioning emricasan as a potential ‘fast follower’ to more advanced programs in the NASH indication. Our goal is to accumulate sufficient and relevant clinical data to allow rapid advancement of emricasan once appropriate regulatory pathways are defined.”