Conatus Announces Completion of Enrollment in ENCORE-LF Phase 2b Clinical Trial of Emricasan

Conatus Pharmaceuticals (NASDAQ:CNAT) has announced it has finished enrollment of ENCORE-LF, a phase 2b clinical trial.

As quoted in the press release:

“With screening in the ENCORE-LF clinical trial complete, we remain on track for clinical events as announced last quarter, with top-line results expected in mid-2019,” said David T. Hagerty, M.D., Executive Vice President of Clinical Development at Conatus. “We sincerely appreciate the participation of these advanced liver disease patients and their contributions to the development of emricasan to address a serious and largely unmet medical need.”

The ENCORE-LF clinical trial is designed to evaluate safety, dosing and efficacy of emricasan in patients with decompensated NASH cirrhosis as an integral part of the company’s initial registration strategy. The double-blind, placebo-controlled, trial is being conducted at approximately 90 U.S. clinical sites in approximately 210 patients with nonalcoholic steatohepatitis (NASH) who have stable decompensated liver cirrhosis. Patients were randomized 1:1:1 to receive 5 mg of emricasan, 25 mg of emricasan, or placebo twice daily for at least 48 weeks. The primary endpoint is event-free survival, which is a composite of all-cause mortality, new decompensation events, or Model for End-stage Liver Disease (MELD) score progression ≥4 points. Analysis of the primary endpoint will be triggered upon reaching a prespecified target number of events. An additional analysis is planned after all patients have completed at least 48 weeks of dosing.

Click here to read the full press release.