Therapy Areas: Vaccines
Pfizer Granted FDA Fast Track Designation for Ervogastat/Clesacostat Combination for the Treatment of Non-Alcoholic Steatohepatitis
27 May 2022 - - The US Food and Drug Administration has granted Fast Track designation to US-based pharmaceutical company Pfizer Inc's (NYSE: PFE) investigational combination therapy for the treatment of non-alcoholic steatohepatitis 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), the company said.

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.

The FDA's decision is informed by the results of Pfizer's nonclinical studies and a Phase 2a clinical study of ervogastat/clesacostat, which showed that treatment with ervogastat/clesacostat reduced liver fat with a favorable safety and tolerability profile. These data were recently published in Nature Medicine.

Pfizer is currently studying ervogastat/clesacostat in an ongoing Phase 2 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 3 development program.

Non-alcoholic steatohepatitis is a serious, progressive form of non-alcoholic fatty liver disease (NAFLD) caused by a buildup of fat in the liver and accompanied by inflammation, liver cell damage, and in some cases scarring of the liver.

Approximately 17m patients in the US are impacted by NASH (and 3-5% of the global adult population), a number that is predicted to grow significantly over the next 10-15 years due to increases in obesity and Type 2 diabetes prevalence and an aging population.

NASH is largely unrecognized and underdiagnosed, increasing patients' risk of morbidity, liver events and mortality.

There are currently no FDA- or EMA-approved medications to treat NASH, and Pfizer researchers are working to develop treatments for the disease to fill this significant unmet medical need.

Diacylglycerol O-acyltransferase 2 (DGAT2) and acetyl-CoA carboxylase are two key enzymes that regulate lipid metabolism.

Inhibitors of ACC and DGAT2 have demonstrated the ability to lower liver fat in patients with non-alcoholic fatty liver disease (NAFLD).

Pfizer believes that ervogastat/clesacostat, its investigational DGAT2i/ACCi combination therapy, has the potential to deliver direct improvements in inflammation and fibrosis.