Novartis and Allergan to conduct Phase IIb trial to treat NASH

Swiss healthcare firm Novartis has entered a clinical trial agreement with Irish pharmaceutical company Allergan to conduct a Phase IIb trial of FXR agonist and cenicriviroc (CVC) combination to treat non-alcoholic steatohepatitis (NASH).

Farnesoid X receptor (FXR) agonists are being developed by Novartis for treating chronic liver diseases.

Allergan's CVC is a potent, once-daily, oral immunomodulator designed to inhibit the chemokine CCR2 and CCR5 receptors associated with inflammatory and fibrogenic pathways.

Under the agreement, the firms will assess the safety, efficacy and tolerability of the combination therapy in the Phase IIb trial.

Novartis drug development global head and chief medical officer Vas Narasimhan said: "Our clinical collaboration with Allergan expands our development programmes 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.

"We believe that collaboration is key to developing the best possible treatments that are urgently needed for NASH patients."

According to the data from the Phase IIb CENTAUR trial, CVC showed a significant improvement in fibrosis without aggravating NASH after one year of treatment.

The product has secured fast-track designation from the US Food and Drug Administration (FDA) for the treatment of NASH and liver fibrosis.

The financial details of the agreement have not been divulged.

Novartis also notified a collaboration and licence agreement in December last year with Conatus Pharmaceuticals for the joint development of an investigational, oral, pan-caspase inhibitor called emricasan for patients with different stages of NASH.