A phase 2b trial of Conatus Pharmaceuticals’ emricasan in nonalcoholic steatohepatitis (NASH) has missed its primary endpoint. The latest setback prompted Novartis-partnered Conatus to lay off 40% of its staff and begin looking for strategic alternatives.
Novartis catapulted Conatus into the limelight in 2016 when it paid $50 million for an option on oral pan-caspase inhibitor emricasan. Since then, emricasan has advanced through a series of readouts that have suggested it poses little threat to the other companies pursuing NASH, culminating in the delivery of data from the phase 2b ENCORE-LF trial.
Neither dose of emricasan outperformed placebo against a primary endpoint that looked at whether patients died, suffered new decompensation events or experienced liver disease progression. There were “no clear trends indicating a potential treatment effect,” Conatus said in a statement.
To compound the failure, Conatus revealed a 24-week extension to one of its four midphase flops also missed the mark. Conatus said the data from the extension were consistent with results from the original 24-week study, which found emricasan was no better than placebo at improving mean hepatic venous pressure gradient in compensated NASH cirrhosis patients.
As it navigated the series of setbacks, Conatus highlighted positives and looked to future trials to generate stronger evidence. But the biotech has now come to the end of the road, with CEO Steven Mento accepting the trials “provided a fair evaluation of emricasan’s lack of efficacy.”
With multiple failed trials to its name, Conatus is set to lay off 40% of its staff, suspend development of preclinical-stage caspase-1 inhibitor CTS-2090 and engage Oppenheimer & Co. to look into strategic alternatives that enable its beleaguered investors to make some money back. Through the changes, Conatus thinks it can end 2019 with up to $15 million in cash, equivalents and marketable securities, buying it the time to search for a way out of its current predicament.
The repeat failures of emricasan have left Conatus with little to offer a potential buyer. Beyond its Nasdaq listing, Conatus’ main asset is CTS-2090. Mento talked up the drug in a release to disclose the reorganization.
“We remain excited by the potential of CTS-2090 as a uniquely positioned inflammasome disease compound,” Mento said. “Although we are halting development activities for CTS-2090, we plan to continue to explore a variety of opportunities to advance this compound.”