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The US FDA has granted FTD to Ervogastat (diacylglycerol O-acyltransferase 2 inhibitor) + Clesacostat (acetyl-CoA carboxylase inhibitor) for the treatment of NASH with liver fibrosis
The designation was based on the results from the nonclinical studies and a P-IIa clinical study to evaluate ervogastat + clesacostat which showed that the combination therapy can reduce liver fat with a favorable safety and tolerability profile. The data were published in Nature Medicine
The combination therapy is currently being evaluated in an ongoing P-II clinical trial to evaluate the impact of treatment on the resolution of NASH or improvement in liver fibrosis. The study is expected to complete in 2024
Ref: Pfizer | Image: Pfizer
