Conatus Pharmaceuticals has completed patient enrolment in ENCORE-PH trial, a Phase IIb study evaluating the safety, dosing and efficacy of emricasan to treat nonalcoholic steatohepatitis (NASH) cirrhosis.
The double-blind, placebo-controlled trial is currently being conducted at around 70 clinical sites in the US and European Union (EU).
Around 240 patients with NASH who have compensated or early decompensated liver cirrhosis and severe portal hypertension confirmed by hepatic venous pressure gradient of ≥12mmHg at baseline have been enrolled in the trial.
As part of the study, patients were randomised at 1:1:1:1 ratio to receive 5mg of emricasan, 25mg of emricasan, 50mg of emricasan, or placebo twice daily for 24 weeks.
The trial’s primary endpoint includes the mean change in hepatic venous pressure gradient (HVPG) from baseline to week 24. Patients will continue to be monitored for clinical results in a six-month treatment extension period.
Top-line results from the trial are expected to be available by the last quarter of this year.
The ENCORE-PH trial is one of the three trials being conducted by Conatus in collaboration with Novartis .
Conatus Pharmaceuticals Clinical Development executive vice-president David Hagerty said: “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.”
Emricasan is an orally active pan-caspase inhibitor designed to reduce the activity of enzymes that mediate inflammation and apoptosis.
By reducing the activity of these enzymes, emricasan could interrupt the progression of various diseases.