- Akero Therapeutics Inc ACRO Has published topline data from the Phase 2b HARMONY study of efruxifermin (EFX) in patients with precirrhotic nonalcoholic steatohepatitis (NASH), stage 2 or 3 (F2-F3) fibrosis.
- The study met its primary endpoint for both the 50 mg and 28 mg EFX dose groups, with 41% and 39% of EFX-treated patients, respectively, achieving at least a one-stage improvement in hepatic fibrosis without worsening NASH by week 24 experienced. compared to 20% for the placebo arm.
- The study also met an important secondary endpoint: 76% and 47% of patients treated with 50 mg and 28 mg, respectively, achieved NASH clearance without worsening fibrosis, compared to 15% for placebo.
- Related: Akero’s lead candidate improves fibrosis in NASH patients with cirrhosis.
- In addition, 41% and 29% of patients treated with 50 mg and 28 mg achieved NASH clearance and fibrosis improvement, respectively, compared to 5% with placebo.
- EFX was generally well tolerated. In both dose groups, the most common adverse events were mild/moderate gastrointestinal events that were transient.
- Akero initiated the Phase 2b SYMMETRY study 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 in addition to GLP-1 therapy in patients with F1-F3 fibrosis are expected in the first half of 2023.
- Price promotion: AKRO shares are up 104.60% to $25.10 during the premarket session last check Tuesday.
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