Akero Therapeutics Inc ACRES shares are trading higher after the company released preliminary week 96 results from HARMONY, a Phase 2b study of its lead product candidate efruxifermin (EFX) for metabolic dysfunction-associated pre-cirrhotic steatohepatitis (MASH), fibrosis stage 2 or 3 (F2-F3).
The study had previously met its primary endpoint of ≥ 1 stage improvement in fibrosis without worsening of MASH after 24 weeks of treatment for both the EFX 50 mg (41%) and EFX 28 mg (39%) dose groups, compared to 20% for the placebo arm.
At week 96, response rates on this endpoint increased to 75% for EFX 50 mg and 46% for EFX 28 mg, compared to 24% for placebo.
The study also met additional histological endpoints at week 96: specifically, 36% and 31% of patients treated with EFX 50 mg and EFX 28 mg experienced a 2-stage improvement in fibrosis without worsening of MASH, i.e. more than 10 times the placebo rate of 3%.
The placebo-adjusted effect size on improvement in fibrosis without worsening of MASH more than doubled between week 24 and week 96 for the 50 mg EFX group, with a slight increase observed for the 28 mg EFX group .
Specifically, placebo-adjusted effect sizes for improvement in fibrosis without worsening of MASH increased from 21% to 52% between week 24 and week 96 for EFX 50 mg and from 20% to 22% for EFX 28 mg.
In a subgroup of patients at highest risk of progression to cirrhosis, 68% and 40% of the EFX 50 mg and EFX 28 mg groups, respectively, experienced at least one stage of fibrosis improvement without worsening of MASH , compared to 14% for placebo.
Analysis of the evolution of responses between weeks 24 and 96 indicated a larger improvement in fibrosis without worsening of MASH and a sustained response, particularly with 50 mg of EFX.
Among patients with biopsies available at week 96 whose fibrosis improved at week 24, 92% and 83% of the 50 mg and 28 mg EFX groups continued to respond, respectively, compared to 40% of the placebo group.
EFX has been reported to be generally well tolerated. There were no deaths. Fifteen serious adverse events were reported, generally balanced between dosing groups.
In October 2023, Akero reported week 36 results for the phase 2b SYMMETRY study in patients with compensated cirrhosis (F4) due to MASH, Child-Pugh class A. Efruxifermin was not statistically significantly better than placebo in improving liver scarring without worsening NASH.
The SYMMETRY trial is designed to include a second biopsy after 96 weeks of treatment, with results expected to be reported in the first quarter of 2025.
Price Action: AKRO shares rose 13.20% to $31.53 on Monday.
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