Allergan has entered into a clinical trial agreement with Novartis to conduct a Phase 2b study, using Allergan’s cenicriviroc (CVC) and Novartis’ lead FXR agonist for the treatment of non-alcoholic steatohepatitis (NASH). The Phase 2b study will assess the safety, efficacy and tolerability of this multi-therapy treatment approach for NASH.

“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 and development officer, Allergan. “Collaboration with companies like Novartis will help us improve our understanding of the disease and deliver effective, high-value medicines for NASH patients. This is also another terrific example of Allergan’s Open Science Research & Development model in action.”

NASH is the progressive form of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver with no other apparent causes. NASH occurs when the accumulation of liver fat is accompanied by inflammation and cellular damage. The inflammation can result in fibrosis (scarring) of the liver and eventually lead to complications such as cirrhosis, portal hypertension, liver cancer and liver failure. There are currently no approved treatments for NASH.

CVC is a once-daily, oral, Phase 3 ready potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are involved in inflammatory and fibrogenic pathways. In the Phase 2b 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 3 endpoints. With its unique Mechanism of Action (MOA) and its favorable safety profile, CVC represents an ideal candidate to become the backbone of NASH multi-therapy treatment. CVC has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in patients with NASH and liver fibrosis.

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 2 clinical trial. As part of this agreement, Novartis and Allergan will conduct a Phase 2b clinical trial to assess the safety, efficacy and tolerability of a multi-therapy treatment for NASH.