Conatus Pharmaceuticals completed enrollment in its ENCORE-PH phase 2 clinical trial for emricasan, an orally-active pan-caspase inhibitor designed to treat nonalcoholic steatohepatitis-related cirrhosis, according to a press release.
“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,” David T. Hagerty, MD, executive vice president of clinical development at Conatus, said in the release.
Researchers designed the double-blind, placebo-controlled trial to evaluate the safety, dosing and efficacy of emricasan in NASH cirrhosis and the trial in collaboration with Novartis.
The investigators will conduct the trial at approximately 70 clinical sites across the U.S. and Europe with approximately 240 patients with NASH, either compensated or early decompensated liver cirrhosis, and severe portal hypertension.
The primary endpoint is the mean change in hepatic venous pressure gradient by 24 weeks, after which the researchers will follow the patients for 6 months to determine clinical outcomes.
Additionally, Conatus announced that it expects top-line results from the ENCORE-NF trial of emricasan for NASH-related fibrosis in the first half of 2019 and top-line results from the ENCORE-LF trial of emricasan for liver function in patients with decompensated NASH cirrhosis in the second half of 2019.