Conatus and Novartis’s Nash project emricasan has struck out for a second time with the failure of the Encore-NF trial in Nash fibrosis. But Conatus seems inexplicably determined to press on. The company admitted yesterday that emricasan, a caspase inhibitor, did not work in the earlier-stage Nash fibrosis patients enrolled in Encore-NF, but suggested it might still have utility in those who had progressed to cirrhosis. One problem with this theory is that the Encore-PH trial, in Nash cirrhosis, failed in December. Still, Encore-PH homed in on patients who also had portal hypertension, so Conatus is clearly clinging to the hope of a different result in its next trial, Encore-LF, in patients with decompensated Nash cirrhosis, the most severe form. The primary endpoint is event-free survival and data are due in mid-2019. Hopes are low, especially after the failed Encore-PH study found a worsening in hepatic venous pressure gradient in a subgroup of decompensated cirrhosis patients treated with 5mg and 25mg of emricasan – the doses being tested in Encore-LF. Conatus shares plunged 56% in premarket trading today. With not much else in its pipeline, it is understandable that the company wants to find a path forward. Novartis might not feel the same.
|Conatus's pipeline programmes|
|Emricasan||Nash cirrhosis with portal hypertension||Encore-PH, NCT02960204||Failed, extension data due mid-2019|
|Emricasan||Nash fibrosis stage F1-F3||Encore-NF, NCT02686762||Failed|
|Emricasan||Decompensated Nash cirrhosis||Encore-LF, NCT03205345||Topline data due mid-2019|
|Emricasan||Combination with Novartis's tropifexor||-||Preclinical; decision to be made by Novartis on clinical development|
|Source: Company website, clinicaltrials.gov.|