Allergan, Novartis to conduct phase 2b trial for combined NASH therapy

Allergan and Novartis have entered a clinical trial agreement to conduct a phase 2b study to assess the safety, efficacy and tolerability of Allergan’s cenicriviroc and Novartis’s lead Farnesoid X receptor agonist as a combined treatment for non-alcoholic steatohepatitis, according to a press release.

“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,” David Nicholson, chief research and development officer at Allergan, said in the release. “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.”

Cenicriviroc, or CVC, is a once-daily, oral immunomodulator that blocks the CCR2 and CCR5 chemokine receptors. CVC demonstrated clinically meaningful improvement in fibrosis of at least one stage without worsening NASH after 1 year of treatment during the phase 2b CENTAUR study and is now considered ready for a phase 3 trial.

Novartis’s lead Farnesoid X receptor agonist is a potent, non-bile acid compound and has recently received Fast Track designation from the FDA. It is currently in a phase 2 clinical trial.

References: www.allergan.com; www.novartis.com