Allergan, Novartis sign NASH clinical trials pact

Allergan is expanding its research and development programme on non-alcoholic steatohepatitis (NASH) through a collaboration with Novartis that will test a new combination therapy approach for the condition.

The firms have signed a clinical trial agreement under which Novartis will carry out a Phase IIb study testing Allergan's cenicriviroc (CVC), a once-daily, oral, Phase III ready potent immunomodulator that blocks the chemokine receptors CCR2 and CCR5, which are involved in inflammatory and fibrogenic pathways, and Novartis' lead FXR agonist for the treatment of NASH.

The study will look at the safety, efficacy and tolerability of this multi-therapy treatment approach for the condition, a progressive form of non-alcoholic fatty liver disease that is reportedly the fastest growing cause of liver cancer and liver transplant in the US.

"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 at 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."

Last September Allergan bought US biotech Tobira Therapeutics in a deal potentially worth up to $1.7 billion, as well as Akarna Therapeutics in a deal worth at least $50 million, securing itself access to a batch of experimental therapies for NASH including CVC.