Akero Heads To Top Of FGF21 Class In NASH; Genfit Says Pandemic Won’t Delay Phase III
Executive Summary
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.
You may also be interested in...
Intercept Plans To Refile OCA For NASH At US FDA With Consensus Reads Of Patient Biopsies
Additional patients and more long-term data could also help make case for obeticholic acid. Intercept hopes to complete its review of the pivotal REGENERATE trial during H1 2022.
Akero First To Show Benefit In Cirrhotic NASH Patients
Although the data are from a small cohort of an ongoing study, Akero’s FGF21 analog reduces fibrosis score by at least one stage in 33% of cirrhotic NASH patients.
Akero Looks To Accelerate Path To Pivotal NASH Data With Phase IIb/III Protocol
Akero gets FDA’s ok to conduct Phase IIb/III study of FGF21 analog efruxifermin in biopsy-confirmed non-alcoholic steatohepatitis patients. With NASH leadership up in the air, Akero, 89bio and other FGF analog sponsors jockey for top spot.