Novartis has entered into a clinical-trial agreement with Allergan to conduct a Phase IIb study involving the combination of a Novartis farnesoid X receptor (FXR) agonist and Allergan’s cenicriviroc (CVC) for treating non-alcoholic steatohepatitis (NASH), a progressive form of non-alcoholic fatter liver disease.

CVC is a once-daily, oral immunomodulator that blocks two chemokine receptors involved in inflammatory and fibrogenic pathways. The compound is ready for Phase III study and has been granted fast track designation by the US Food and Drug Administration (FDA) for treating NASH and liver fibrosis. Novartis is developing FXR agonists for treating chronic liver diseases, including NASH. Its lead investigational compound is a non-bile acid FXR agonist, which recently received fast track designation from the FDA and is in a Phase II clinical trial.

As part of this agreement, Novartis and Allergan will conduct a Phase IIb clinical trial to assess the safety, efficacy and tolerability of a combination therapy for NASH. The financial details of this transaction were not disclosed.

In December 2016, Novartis announced an exclusive option for a collaboration and license agreement with Conatus Pharmaceuticals, a San Diego, California-based biopharmaceutical company specializing in liver diseases, to jointly develop emricasan, an investigational oral pan-caspase inhibitor, for NASH. Both collaborations with Conatus and Allergan support Novartis’ portfolio for chronic liver disease therapies.

Source: Novartis