Akero Therapeutics announces efruxifermin granted BTD from U.S. FDA

Akero Therapeutics announced that efruxifermin, EFX, has received a Breakthrough Therapy Designation, BTD, from the US Food and Drug Administration, FDA, for the treatment of nonalcoholic steatohepatitis, NASH. "We are proud to have the FDA recognize the potential therapeutic benefit of EFX through this Breakthrough Therapy Designation," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "With the global prevalence of NASH continuing to rise, we are committed more than ever to developing therapeutics that can treat NASH holistically and reverse fibrosis rapidly. This designation is an important milestone for Akero and the NASH community as we continue to evaluate EFX as a potential foundational monotherapy." In HARMONY, Akero observed that both 50mg and 28mg doses of EFX produced at least a one stage improvement in liver fibrosis with no worsening of NASH by week 24 compared with 20% for placebo. In addition to meeting this primary endpoint, the study also met two key secondary endpoints with 76% and 47% of patients treated with 50mg and 28mg, respectively, achieving NASH resolution without worsening of fibrosis, compared with 15% for placebo. An additional Phase 2b study, SYMMETRY, was initiated in July of 2021. Akero expects to report results from the ongoing SYMMETRY study in the second half of 2023. Results from a 12-week expansion cohort of the SYMMETRY study, evaluating treatment of EFX in combination with GLP-1 therapy in patients with F1-F3 fibrosis, are expected in the first half of 2023.