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Akero Therapeutics Shares More Than Double After Lead NASH Candidate Aces Mid-Stage Study

Published 13/09/2022, 12:49
© Reuters. Akero Therapeutics Shares More Than Double After Lead NASH Candidate Aces Mid-Stage Study
AKRO
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  • Akero Therapeutics Inc (NASDAQ: AKRO) has released topline data from HARMONY Phase 2b study of efruxifermin (EFX) in patients with pre-cirrhotic nonalcoholic steatohepatitis (NASH), fibrosis stage 2 or 3 (F2-F3).
  • The study met its primary endpoint for both the 50mg and 28mg EFX dose groups, with 41% and 39% of EFX-treated patients, respectively, experiencing at least a one-stage improvement in liver fibrosis with no worsening of NASH by week 24, compared with 20% for the placebo arm.
  • The study also met a key secondary endpoint with 76% and 47% of patients treated with 50mg and 28mg, respectively, achieving NASH resolution without worsening fibrosis, compared with 15% for placebo.
  • Related: Akero Lead Candidate Improves Fibrosis In Cirrhotic NASH Patients.
  • In addition, 41% and 29% of patients treated with 50mg and 28mg achieved NASH resolution and fibrosis improvement compared with 5% for placebo.
  • EFX was generally well tolerated. Across both dose groups, the most frequent adverse events were mild/moderate gastrointestinal events, which were transient.
  • Akero initiated the SYMMETRY Phase 2b trial in NASH patients with compensated cirrhosis (F4), Child-Pugh class A.
  • Results are expected in the second half of 2023. Results from an expansion cohort of the SYMMETRY study of EFX on top of GLP-1 therapy in patients with F1-F3 fibrosis are expected in 1H of 2023.
  • Price Action: AKRO shares are up 104.60% at $25.10 during the premarket session on the last check Tuesday.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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