US FDA grants fast track designation to Pfizer’s ervogastat/clesacostat combination to treat NASH

The US Food and Drug Administration (FDA) has granted fast track designation to Pfizer’s investigational combination therapy for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis: ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi). Fast Track is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address unmet medical need, Pfizer informed yesterday via a statement.

The statement said that the FDA’s decision is informed by the results of Pfizer’s non-clinical studies and a phase-IIa clinical study of ervogastat/clesacostat, which showed that treatment with ervogastat/clesacostat reduced liver fat with a favourable safety and tolerability profile. These data were recently published in Nature Medicine.

Pfizer is currently studying ervogastat/clesacostat in an ongoing phase-II clinical trial evaluating the impact of treatment on resolution of NASH or improvement in liver fibrosis (NCT04321031), expected to complete in 2024. The results of this study, which also includes arms investigating ervogastat as monotherapy, will inform a potential phase-III development programme, the statement concluded.