Akero Therapeutics New Analyses For Efruxifermin Shows Rapid, Substantial Liver Fat Reduction In NASH Patients

  • Akero Therapeutics Inc AKRO has announced additional analyses from its Phase 2a BALANCED study of efruxifermin (EFX) in non-alcoholic steatohepatitis (NASH) patients with F1-F3 fibrosis.
  • Data were presented at the 2021 International Liver Congress. 
  • These analyses show significant correlations between normalization of liver fat and improvements in markers of liver injury and fibrosis, as well as whole-body metabolism. 
  • The new analyses also show that combining ALT response of more than 17 U/L with normalization of liver fat increases the power to predict resolution of NASH.
  • More than 50% reduction in liver fat content was observed in 69% of the patients in the 28mg EFX group, 100% patients in the 50mg EFX arm, and 93% in the 70mg EFX group at week 12.
  • Over 70% liver fat reduction was seen in 50%, 53%, and 80% of the patients in the three dose groups.
  • Only 5% of the patients achieved a liver fat reduction of over 50% or 70% in the placebo arm.
  • Normalization of liver fat content was reported in 25%, 53%, and 67% of the patients in the three dose groups.
  • EFX is currently being evaluated in a Phase 2b HARMONY trial in F2/F3 fibrosis patients.
  • A second Phase 2b trial in patients with Cirrhotic (F4) NASH is planned for the second half of 2021.
  • Price Action: AKRO shares are down 0.65% at $29.76 on the last check Monday.
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