Conatus Announces Completion Of Enrollment In ENCORE-NF Phase 2b Clinical Trial Of Emricasan In Patients With NASH Fibrosis

SAN DIEGO, Aug. 14, 2017 (GLOBE NEWSWIRE) -- Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) today announced the completion of enrollment in ENCORE-NF, 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 330 patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) and stage 1 to 3 fibrosis using the NASH Clinical Research Network (CRN) Histologic Scoring System. This trial is designed to evaluate the long-term safety and efficacy of emricasan in patients with NASH fibrosis as well as support the initial registration focus in liver cirrhosis.

"We are pleased to have completed enrollment in the ENCORE-NF clinical trial in this highly competitive NASH fibrosis field," said David T. Hagerty, M.D., Executive Vice President of Clinical Development at Conatus. "We would like to thank the patients and the investigators who are participating in the trial, and all the study teams who helped us reach this important milestone. Emricasan's ability to improve both liver fibrosis and liver inflammation has been demonstrated in preclinical models of NASH, and we look forward to helping advance this novel product candidate to address the substantial unmet medical needs of NASH fibrosis patients."

The ENCORE-NF clinical trial is being conducted at approximately 100 U.S. and EU clinical sites. Patients were randomized 1:1:1 to receive 5 mg of emricasan, 50 mg of emricasan, or placebo twice daily for 72 weeks. The primary endpoint is a biopsy-based improvement in fibrosis by at least one stage vs. placebo using NASH CRN without worsening of steatohepatitis. Secondary endpoints include resolution of steatohepatitis without worsening of fibrosis, nonalcoholic fatty liver disease (NAFLD) activity score (NAS) and its components (steatosis, lobular inflammation, and ballooning), collagen and fat content by biopsy, key serum biomarkers, and health-related quality of life, as well as safety and tolerability.

Emricasan Clinical Development

In collaboration with Novartis, Conatus is conducting four randomized, double-blind, placebo-controlled Phase 2b clinical trials designed to evaluate emricasan treatment in various patient populations, including three in the Emricasa N, a Caspase inhibit OR, for Evaluation (ENCORE) series in patients with fibrosis or cirrhosis caused by NASH, and a fourth in POLT-HCV-SVR patients:
  • ENCORE-NF (for NASH Fibrosis), initiated in the first quarter of 2016, in approximately 330 patients with NASH fibrosis, with top-line results expected in the first half of 2019; 
  • ENCORE-PH (for Portal Hypertension), initiated in the fourth quarter of 2016, in approximately 240 patients with compensated or early decompensated NASH cirrhosis and severe portal hypertension, with top-line results expected in 2018 followed by an integrated 6-month treatment extension period for clinical outcomes; 
  • ENCORE-LF (for Liver Function), initiated in the second quarter of 2017, in approximately 210 patients with decompensated NASH cirrhosis, with top-line results expected in 2019; and 
  • POLT-HCV-SVR, initiated in the second quarter of 2014, in approximately 60 post-orthotopic liver transplant (POLT) recipients with liver fibrosis or cirrhosis post-transplant as a result of recurrent HCV infection who have successfully achieved a sustained viral response (SVR) following HCV antiviral therapy, with top-line results expected in the first half of 2018.

Results from the four ongoing emricasan clinical trials are expected to support the design of Phase 3 clinical efficacy and safety trials.

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