Conatus Pharmaceuticals Inc. (CNAT)

[Theo]

Conatus Announces Completion of Enrollment in ENCORE-PH Phase 2b Clinical Trial of Emricasan in Patients with NASH Cirrhosis and Severe Portal Hypertension

"SAN DIEGO, April 30, 2018 (GLOBE NEWSWIRE) -- Conatus Pharmaceuticals Inc. (CNAT) today announced the completion of enrollment in ENCORE-PH, a Phase 2b clinical trial evaluating emricasan, the company’s first-in-class, orally-active pan-caspase inhibitor. Top-line results from the ENCORE-PH clinical trial are expected in the fourth quarter of 2018.

“We were pleased to complete enrollment in the ENCORE-PH clinical trial on schedule,” said David T. Hagerty, M.D., Executive Vice President of Clinical Development at Conatus. “We thank the patients for participating in the trial, the clinical investigators and sites that met our stringent HVPG qualification criteria for conducting the trial, and the site monitoring teams for facilitating this timely achievement. We look forward to the upcoming series of emricasan clinical trial readouts and the potential opportunity to advance this novel product candidate toward addressing the unmet medical needs of NASH fibrosis and cirrhosis patients.”

The ENCORE-PH clinical trial is designed to evaluate safety, dosing and efficacy of emricasan in NASH cirrhosis as an integral part of the company’s initial registration strategy. The double-blind, placebo-controlled trial is being conducted at approximately 70 U.S. and EU clinical sites in approximately 240 patients with nonalcoholic steatohepatitis (NASH) who have compensated or early decompensated liver cirrhosis and severe portal hypertension confirmed by hepatic venous pressure gradient (HVPG) of ≥12 mmHg at baseline. Patients were 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 in HVPG from baseline to Week 24. Patients will continue to be followed for clinical outcomes in a six-month treatment extension period.

Emricasan Clinical Development
In collaboration with Novartis, Conatus is conducting three randomized, double-blind, placebo-controlled Phase 2b clinical trials, the EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) trials, designed to evaluate emricasan in patients with fibrosis or cirrhosis caused by NASH:

ENCORE-PH (for Portal Hypertension), initiated in the fourth quarter of 2016, with top-line results expected in the fourth quarter of 2018, as described above;

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; and

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 the second half of 2019."