On June 24, Novartis announced that Emricasan (VAY785), developed in collaboration with Conatus Pharmaceuticals, failed to meet the primary endpoint in the Phase IIb ENCORE-LF trial for the treatment of non-alcoholic steatohepatitis (NASH).
This study enrolled a total of 217 patients with nonalcoholic steatohepatitis (NASH), who were randomized into two groups to receive either emricasan or placebo for a treatment duration of 48 weeks. The primary endpoint was event-free survival, defined as the absence of all-cause mortality, new decompensation events, and an increase in the Model for End-Stage Liver Disease (MELD) score of at least 4 points. The results showed no statistically significant difference between the experimental group and the placebo group, nor was there any apparent trend suggesting potential therapeutic benefit.
Emricasan is a first-in-class pan-caspase inhibitor developed by Conatus Pharmaceuticals. On December 19, 2016, Novartis entered into a collaboration agreement with Conatus Pharmaceuticals to strengthen its NASH research efforts, under which Novartis paid Conatus Pharmaceuticals an upfront fee of $50 million. In February and May 2017, Novartis made additional payments of $15 million and $7 million, respectively, to secure full rights to the drug.
Conatus Pharmaceuticals announced that it would reassess its strategic options, implement a 40% reduction in its workforce, and discontinue the development of its investigational inflammasome disease candidate, CTS-2090. Steven Mento, CEO of Conatus, stated, “While the company is excited about the potential of CTS-2090 to treat inflammatory diseases, we must preserve our remaining resources to extend our cash runway and deliver value to shareholders.”