Emricasan fails to meet primary endpoint in NASH-cirrhosis trial
Emricasan did not meet its either of its primary phase 2b trial endpoints in patients with nonalcoholic steatohepatitis-related decompensated cirrhosis, according to a press release from Conatus Pharmaceuticals. The company also stated that it is discontinuing further treatment of enrolled patients.
“We designed the ENCORE program to give emricasan an opportunity to achieve its potential through a series of clinical trials tailored to specific patient populations encompassing a broad range of chronic liver disease,” Steven J. Mento, PhD, president, CEO and cofounder of Conatus, said in the release. “We are disappointed that emricasan failed to meet the expectations established in prior preclinical and clinical studies, but confident that the ENCORE trials provided a fair evaluation of emricasan’s lack of efficacy in these patient populations.”
The randomized control ENCORE-LF trial comprised 217 patients who received 5 mg or 25 mg of emricasan or placebo twice daily for at least 48 weeks. The primary endpoint of event-free survival — defined as a composite of all-cause mortality, new decompensation events, or a progression in MELD score of 4 points or more — was not significantly different between treatment and placebo groups.
Additionally, Conatus announced that results from a 24-week extension of the ENCORE-PH phase 2b trial were consistent with results from the initial 24-week treatment period in which patients with NASH and either compensated or decompensated cirrhosis and severe portal hypertension did not show significant change in mean hepatic venous pressure gradient compared with placebo.
“We offer sincere thanks to the patients, principal investigators, collaborators, service providers and investors who enabled the development of emricasan,” David T. Hagerty, MD, executive vice president of clinical development at Conatus, said in the release. “We offer hope that the scientific and clinical communities will build on the knowledge gained from these efforts in their continued pursuit of new treatment alternatives for chronic liver disease.”
Conatus stated that the company will continue to work with its partner Novartis on ensuring that all remaining obligations related to the emricasan program are fulfilled.