Conatus Initiates Phase 2b ENCORE-PH Clinical Trial Of Emricasan In Patients With NASH Cirrhosis

SAN DIEGO, Nov. 03, 2016 (GLOBE NEWSWIRE) -- Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) today announced the initiation of ENCORE-PH (PH for Portal Hypertension), a randomized, double-blind, placebo-controlled, Phase 2b clinical trial evaluating emricasan, the company's first-in-class, orally-active pan-caspase inhibitor, in approximately 240 patients with compensated or early decompensated liver cirrhosis caused by nonalcoholic steatohepatitis (NASH), and severe portal hypertension confirmed by hepatic venous pressure gradient (HVPG) of =12 mmHg at baseline. This trial is designed to evaluate dosing, efficacy and safety of emricasan in NASH cirrhosis as an integral part of the company's initial registration strategy. Top-line results from the ENCORE-PH clinical trial are expected in 2018.

The ENCORE-PH clinical trial is expected to be conducted at approximately 90 U.S. and EU clinical sites. Patients will be randomized 1:1:1:1 to receive 5 mg of emricasan, 25 mg of emricasan, 50 mg of emricasan, or placebo twice daily for 24 weeks. The primary endpoint is the mean change from baseline in HVPG at 24 weeks for each dosing group compared with the placebo group. Key secondary endpoints include safety and tolerability, dose response, and percentage of patients achieving at least a 20% reduction in HVPG. Additional key endpoints include initial or subsequent decompensation events, changes from baseline in Model for End-stage Liver Disease (MELD) and Child-Pugh scores, and health-related quality of life. Select sites will also investigate whether emricasan improves liver stiffness as measured by Fibroscan® transient elastography and liver metabolic function using the BreathID® Methacetin Breath Test at screening and at Week 24.

"ENCORE-PH is a key component of our clinical strategy designed to support an initial registration of emricasan in NASH cirrhosis," said Conatus co-founder, President and Chief Executive Officer Steven J. Mento, Ph.D. "Portal hypertension, a major consequence of advancing liver cirrhosis, is a driving factor in clinical outcomes such as ascites and variceal hemorrhage, as well as liver failure and death. The primary endpoint, HVPG, has been identified as a validated surrogate endpoint potentially suitable for registration. Results released last year from our open label pilot Portal Hypertension clinical trial and results from preclinical studies have demonstrated emricasan's ability to reduce HVPG rapidly and significantly through both intrahepatic and extrahepatic mechanisms. We believe that chronic administration of emricasan, which would be supported by the longer treatment duration being evaluated in ENCORE-PH, will lead to additional benefits for cirrhosis patients."

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