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Akero Heads To Top Of FGF21 Class In NASH; Genfit Says Pandemic Won’t Delay Phase III

 
• By Joseph Haas

Akero’s FGF21 analog yields 63%-72% relative hepatic fat reduction in Phase IIa study; the company awaits biopsy data hoping to see a fibrotic benefit. Also, Genfit says COVID-19 pandemic should not significantly delay its Phase III NASH readout.

Human Liver Anatomy. 3D
Akero has data showing its FGF21 analog can reduce hepatic fat; now it hopes to see a fibrosis benefit in NASH patients

FGF21 analogs comprise one of the more crowded classes in non-alcoholic steatohepatitis (NASH) drug development, with major players like Merck & Co. Inc. and Bristol-Myers Squibb Co.in the field, but Akero Therapeutics Inc. may be moving to front of the pack with Phase IIa data for its drug showing an ability to produce relative hepatic fat reduction ranging from 63%-72%.

On 31 March, the recently-turned-public firm revealed that its BALANCED study met its primary endpoint of hepatic fat reduction from baseline compared to placebo, with 28mg, 50mg and 70mg doses of the once-weekly injectable all hitting that mark. Akero licensed AKR-001 from Amgen Inc., after that firm made the compound available for out-licensing following Phase I investigation in type 2 diabetes

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