Monday, June 24, 2024

Akero plummets after mid-stage data for NASH candidate

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  • Akero Therapeutics (NASDAQ:AKRO) fell ~63% pre-market Tuesday after the company posted interim data from its Phase 2b SYMMETRY trial for its lead candidate efruxifermin (EFX) in patients with liver disorder nonalcoholic steatohepatitis (NASH).
  • Other developers of NASH drugs such as 89bio (ETNB), CohBar (CWBR), Axcella Health (AXLA), and Lipocine (LPCN) were also down in reaction.
  • AKRO’s 96-week trial was designed to evaluate once-weekly subcutaneous EFX in 28mg and 50mg doses versus placebo in NASH patients with compensated cirrhosis.
  • The company said that 22% (28mg) and 24% (50mg) of those on EFX and 14% on placebo indicated at least one stage improvement in fibrosis with no worsening of NASH at week 36, the trial’s primary endpoint.
  • Meanwhile, 63% (28mg) and 60% (50mg) of patients on EFX and 26% on placebo experienced NASH resolution with a statistically significant effect.
  • As for safety, there were 21 serious adverse events, none of which were treatment-related, according to investigators. However, 12 patients, including 11 in EFX groups, discontinued the trial due to drug-related adverse events, mostly grade 1-2 diarrhea, AKRO added.

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