Novartis said it is collaborating with Allergan in a Phase IIb clinical trial to test a combination therapy for treating non-alcoholic steatohepatitis (NASH), a chronic, progressive form of non-alcoholic fatty liver disease.
The trial will evaluate the Farnesoid X receptor (FXR) agonist developed by Novartis in combination with Allergan's cenicriviroc (CVC). CVC has already undergone the Phase IIb CENTAUR study, Novartis said in a release. The participants in the CENTAUR trial saw an improvement in liver fibrosis, or scarring, without increasing NASH progression. The new Phase IIb trial will evaluate the combination therapy for safety, efficacy and tolerability in treating NASH.
"Our clinical collaboration with Allergan expands our development programs for NASH, bringing together science and expertise to investigate a potential new combination therapy in an effort to make a positive change for people living with this condition," Novartis Global Head, Drug Development and Chief Medical Officer Vas Narasimhan said in the release. "We believe that collaboration is key to developing the best possible treatments that are urgently needed for NASH patients."
Currently there is no approved treatment for NASH. As the disease progresses, fat accumulates in the liver, which also becomes inflamed and scarred. NASH can lead to cirrhosis and liver failure. It is the leading cause of liver transplants in U.S. patients under age 50.