Akero's lead product candidate, efruxifermin (EFX), is a differentiated bivalent Fc-FGF21 fusion protein. EFX is currently being evaluated in two Phase IIb clinical trials: the HARMONY study in patients with pre-cirrhotic NASH, and the SYMMETRY study in patients with cirrhotic NASH.
EFX is also being evaluated in an expansion cohort of the SYMMETRY study, comparing the safety and tolerability of EFX to placebo when added to an existing GLP-1 receptor agonist in patients with pre-cirrhotic NASH and Type II diabetes.
In December 2022, the USA-based company announced that EFX received a Breakthrough Therapy designation from the US FDA for the treatment of NASH.
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