Allergan, Novartis to Conduct Clinical Trial to Treat NASH

Allergan, a leading global biopharmaceutical company, 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 multitherapy treatment approach for NASH.

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.ii 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 endpo ints.