Novartis expands development programs for NASH through clinical collaboration with Allergan - Seite 2

Novartis is developing Farnesoid X receptor (FXR) agonists for the treatment of chronic liver diseases, including NASH.  The most advanced investigational compound is a potent, non-bile acid FXR agonist, which recently received Fast Track designation from the FDA and is in a Phase II clinical trial. As part of this agreement, Novartis and Allergan will conduct a Phase IIb clinical trial to assess the safety, efficacy and tolerability of a combination therapy for NASH. 

In December 2016, Novartis announced an exclusive option for a collaboration and license agreement with Conatus Pharmaceuticals Inc. to jointly develop emricasan for NASH. Emricasan is an investigational, first-in-class, oral, pan-caspase inhibitor and our agreement with Conatus has the potential to expand treatment options for people in various stages of NASH, including those with the advanced form of the disease, NASH cirrhosis. Both collaborations with Conatus and Allergan continue to support the growing Novartis portfolio to develop new therapies in chronic liver diseases, including NASH.

About Novartis FXR agonists
Novartis scientists began to develop leads for the FXR agonism program in 2007. Through this effort, several non-bile acid FXR agonists have been identified and pre-clinical data demonstrates that these compounds are very selective with differentiated biological profiles. 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. First-in-human studies have continued to support their differentiated profiles and their potential for further development. Two Novartis FXR agonists are now in worldwide clinical studies in NASH patients and both have received Fast Track designation status from the FDA.

About Non-Alcoholic Steatohepatitis (NASH)
NASH is a chronic, progressive form of non-alcoholic fatty liver disease. It is a leading cause of liver disease worldwide and it is estimated to affect 3% to 5% of the US population alone[2]. As fat builds up in the liver, it triggers a vicious cycle of chronic inflammation and liver scarring called fibrosis. Over time, liver inflammation and fibrosis may progress to cirrhosis, which can lead to liver failure and, barring a transplant, death. NASH is expected to be the principal cause of liver transplantation in the US by 2020[3] and is currently the leading cause of liver transplants for people under 50 in the US[1].