Novartis Expands Liver Disease Portfolio

Novartis recently entered into a collaboration and license agreement with Conatus Pharmaceuticals to develop new drugs for chronic liver disease.

Under the agreement, the companies will co-develop emricasan, an investigational pan-caspase inhibitor for the treatment of non-steatohepatitis (NASH) with advanced fibrosis and cirrhosis.

NASH is a chronic liver disease characterized by chronic inflammation and scarring due to fat build-up in the liver. The disease may progress to liver cirrhosis, which could then lead to liver failure, hepatocellular carcinoma, and even death if transplantation is not available.

The new collaboration has the potential to expand treatment options for patients with this liver disease, where there are currently no approved treatments, according to a press release from Novartis. Due to this lack of treatment options, it is expected that NASH will become the number 1 reason for liver transplants by 2020.

It is the hope that this new collaboration will produce an effective treatment option for patients with NASH to avoid poor health outcomes and high costs.

Novartis will make a payment of $50 million to Conatus, and additional exercise fees will also be paid following the achievement of outlined criteria, such as approvals.

Under the terms of the new agreement, Conatus will conduct phase 2b studies of emricasan. The company has already conducted initial phase 2 studies of the drug, according to Novartis. If results are positive, Novartis will conduct phase 3 studies of the drug as a monotherapy, and explore combination treatment options.

Currently, Novartis is developing multiple Farnesoid X receptor (FXR) antagonists to treat chronic liver diseases, such as NASH. FXR antagonists have shown the ability to reduce fat, inflammation, and fibrosis in the liver, which are 3 of NASH characteristics.

The drug’s ability to reduce the symptoms of NASH make it an ideal candidate for a combination treatment with emricasan, Novartis reported.

The most potent investigational non-bile acid FXR antagonist has recently been granted fast track designation by the FDA for the treatment of NASH with fibrosis. The drug is currently in phase 2 clinical trials, according to Novartis.

To date, emricasan has been studied in more than 650 patients across 16 clinical trials, and has shown significant and sustained reduction in inflammation and cell death. The FDA has also granted this drug fast track designation.

"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, Drug Development and chief medical officer, Novartis. "Emricasan shows great promise as a single agent and in potential combination with our internal FXR agonists as a treatment for NASH patients.”