Akero Therapeutics Outlines Expected 2023 Milestones For Lead NASH Program

  • Akero Therapeutics Inc AKRO completed enrollment of the Phase 2b SYMMETRY main study evaluating efruxifermin (EFX) for non-alcoholic steatohepatitis (NASH) in patients with compensated cirrhosis fibrosis stage 4 (F4). 
  • Enrollment is also complete for the expansion cohort, known as Cohort D, evaluating EFX in combination with GLP-1 therapy in patients with fibrosis stage 1-3 (F1-F3) and Type 2 Diabetes.
  • One hundred eighty-two patients have been randomized to receive once-weekly subcutaneous dosing of 28mg EFX, 50mg EFX, or placebo. 
  • Related: Akero Therapeutics Shares More Than Double After Lead NASH Candidate Aces Mid-Stage Study.
  • The primary endpoint for the trial is fibrosis regression after 36 weeks of treatment. Secondary measures include change from baseline in liver enzymes, liver fat, lipoproteins, glycemic control, and body weight at 36 weeks, as well as safety and tolerability. 
  • To provide additional safety data from long-term follow-up, patients will continue to receive EFX or a placebo from 36 to 96 weeks.
  • Results from the Cohort D expansion cohort are expected in the second quarter of 2023, while results from the main study remain on track to be reported in the fourth quarter of 2023.
  • Following the designation of EFX as a Breakthrough Therapy by the FDA, an End-of-Phase 2 meeting has been scheduled for March 2023 to review the HARMONY F2/3 data and the proposed Phase 3 clinical program.
  • Price Action: AKRO shares closed at $45.14 on Wednesday.
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