Novartis has entered into a clinical trial agreement with Allergan plc to conduct a Phase IIb study, involving the combination of a Novartis FXR agonist and Allergan's cenicriviroc (CVC) for the treatment of non-alcoholic steatohepatitis (NASH).
NASH is the progressive form of non-alcoholic fatty liver disease, characterised by the accumulation of fat in the liver, inflammation and fibrosis (scarring), which can eventually lead to cirrhosis and liver failure. NASH is a major cause of liver disease worldwide and the leading cause of liver transplants for people under 50 in the US. There are currently no approved treatments for the disease.
Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis, said: "We believe that collaboration is key to developing the best possible treatments that are urgently needed for NASH patients."
The financial details of the deal were not disclosed.
CVC is a once-daily, oral, Phase III ready potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are involved in inflammatory and fibrogenic pathways. In the Phase IIb CENTAUR study, CVC demonstrated a clinically meaningful improvement in fibrosis of at least one stage without worsening of NASH after one year of treatment, which is one of only two approvable Phase III endpoints.
Novartis is developing Farnesoid X receptor 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.