Akero Therapeutics is a clinical-stage biotechnology company focused on developing transformational treatments for serious metabolic diseases, including non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH). The CEO is Dr. Andrew Change and the CSO is Dr. Tim Rolph. Efruxfermin is an Fc-FGF21 fusion protein engineered to mimic the biological activity of fibroblast growth factor 21 (FGF21). FGF21 regulates multiple metabolic pathways and cellular processes. By delivering sustained and balanced signaling through FGF21’s receptors in the liver and adipose tissue, EFX aims to address the core drivers of MASH progression. A Phase 2 study, known as the HARMONY Study evaluated EFX patients with pre-cirrhotic MASH (fibrosis stages 2 or 3) was initiated, with enrollment completion announced in February 2022. Topline results from this study were presented in March 2024. A Phase 2b study assessing EFX in patients with compensated cirrhosis due to NASH (fibrosis stage 4) was initiated in July 2021. Topline results from this study were presented in October 2023. Currently a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study entitled Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Compensated Cirrohosis Due to NASH/MASH is underway.
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