Novartis expands development programs for NASH through clinical collaboration with Allergan

Novartis International AG / Novartis expands development programs for NASH through clinical collaboration with Allergan . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Phase IIb clinical trial to evaluate a combination of a Novartis FXR agonist and Allergan's cenicriviroc for NASH, a progressive  form of non-alcoholic fatty liver disease
   

There are currently no approved treatments for NASH, which is a major cause of liver disease worldwide and the leading cause of liver transplants for people under 50 in the US[1]
 

Novartis has a rapidly growing development portfolio in NASH, investigating single and combination therapies across all stages of the disease

Basel, April 18, 2017 - Novartis announced today that it 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). The financial details of this transaction are not disclosed.

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. NASH is a major cause of liver disease worldwide and the leading cause of liver transplants for people under 50 in the US[1].  There are currently no approved treatments for 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," 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."

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. 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 US Food and Drug Administration (FDA) in patients with NASH and liver fibrosis.