The Food and Drug Administration (FDA) has granted Fast Track status to the combination of ervogastat and clesacostat for the treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Ervogastat is a diacylglycerol O-acyltransferase 2 inhibitor and clesacostat is an acetyl-CoA carboxylase inhibitor. Inhibition of these 2 enzymes has been associated with a reduction in hepatic steatosis in patients with nonalcoholic fatty liver disease.

The investigational combination received the designation based on preclinical data and findings from a phase 2a clinical trial that indicated the treatment was safe and tolerable. The phase 2 MIRNA trial (ClinicalTrials.gov Identifier: NCT04321031) is currently investigating the effect of ervogastat combined with clesacostat, as well as ervogastat alone, on resolution of NASH or improvement in liver fibrosis. The study is expected to be completed in 2024.

“Receiving Fast Track designation from the FDA reinforces Pfizer’s belief in ervogastat/clesacostat as a potential treatment for NASH, a serious, progressive liver disease with no currently approved therapies,” said James Rusnak, MD, PhD, Senior Vice President and Chief Development Officer, Internal Medicine and Hospital, Pfizer.

Reference

Pfizer granted FDA Fast Track designation for ervogastat/clesacostat combination for the treatment of non-alcoholic steatohepatitis (NASH). News release. May 26, 2022. https://www.businesswire.com/news/home/20220526005017/en/Pfizer-Granted-FDA-Fast-Track-Designation-for-ErvogastatClesacostat-Combination-for-the-Treatment-of-Non-Alcoholic-Steatohepatitis-NASH