Novartis and Allergan have joined forces in a Phase IIb study to test combination of a Novartis’ FXR agonist and Allergan’s cenicriviroc (CVC) to treat non-alcoholic steatohepatitis (NASH).
NASH is the progressive form of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver, inflammation and fibrosis (scarring), and can eventually lead to cirrhosis and liver failure, the companies explained. There are currently no approved treatments for NASH, even though it is major cause of liver disease worldwide and the leading cause of liver transplants for people under 50 in the US, the companies said.
According to the agreement, Novartis and Allergan will test the combination in a Phase IIb clinical trial for the safety, efficacy and tolerability of a combination therapy for NASH.
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, Novartis said.
“Our clinical collaboration with Novartis brings together our collective scientific and development expertise in NASH to focus on multi-therapy treatment, which is expected to be the most likely approach based on the multi-factorial aspects of this disease,” said David Nicholson, Chief Research & Development Officer, Allergan.
“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,” said Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. “We believe that collaboration is key to developing the best possible treatments that are urgently needed for NASH patients.”