Novartis signed an exclusive option, collaboration, and license agreement with Conatus Pharmaceuticals, a company specializing in the treatment of liver diseases. Under the terms of this agreement, Novartis will make an upfront payment to Conatus of $50 million.
The two companies will jointly develop emricasan—an oral, pan-caspase inhibitor for the treatment of nonalcoholic steatohepatitis (NASH) with advanced fibrosis and cirrhosis. This collaboration has the potential to develop therapies for patients in various stages of fatty liver disease, where no approved medicines currently exist.
“Our collaboration with Conatus is a major step forward to delivering innovative oral treatments for NASH patients, who are in urgent need of new approved options,” said Vasant Narasimhan, global head of drug development and CMO, Novartis. “Emricasan shows great promise as a single agent and in potential combination with our internal FXR agonists as a treatment for NASH patients.”
Novartis is currently developing farnesoid X receptor (FXR) agonists for the treatment of chronic liver diseases. FXR agonists have been shown to address three of the most important aspects of NASH progression by reducing fat, inflammation, and fibrosis in the liver. The most advanced Novartis investigational compound, a potent, non-bile acid FXR agonist, has recently received Fast Track designation from the FDA for NASH with liver fibrosis and is in a Phase II trial.
As part of this collaboration, Conatus will conduct multiple Phase IIb trials with emricasan in NASH. If concluded positively, Novartis would then conduct Phase III studies of emricasan as a single treatment and start development of combination therapies with an FXR agonist. Emricasan has been studied in 16 clinical trials across a broad range of liver diseases, including multiple clinical Phase II trials conducted by Conatus, where it has demonstrated significant, rapid, and sustained reductions in elevated levels of key biomarkers of inflammation and cell death in liver diseases.
This has been a busy week for Novartis, with their recent acquisition of Ziarco.