Allergan and Novartis join forces to develop NASH combo therapy

Allergan and Novartis have announced a new partnership to conduct a clinical trial in the treatment area of non-alcoholic steatohepatitis (NASH), evaluating two of their treatments as a combination therapy.

The agreement will lead to a Phase 2 trial investigating the safety and efficacy of Allergan’s cenicriviroc and Novartis’ lead Farnesoid X receptor (FXR) agonist as a multi-therapy approach to treating NASH. The illness is a progressive form of non-alcoholic fatty liver disease (NAFLD) which manifests when the associated accumulation of liver fat begins to cause inflammation and cellular damage, eventually leading to scarring (fibrosis) and cirrhosis, and even liver cancer and failure.

Cenicriviroc is an immunomodulator which blocks chemokine receptors CCR2 and CCR5 and has shown in Phase 2 trials to improve fibrosis without disease progression of NASH after one year of treatment. The drug has already been fast-tracked for approval by the FDA in the indications of NASH and liver fibrosis.

Novartis’ lead FXR agonist meanwhile is a non-bile acid candidate currently in Phase 2 trials, and also boasts Fast-Track designation from the FDA.

"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," explained David Nicholson, Chief Research & 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."

Neither company disclosed the financial details of the agreement.