Akero Therapeutics' Stock Is Soaring Monday - Here's Why

Akero Therapeutics Inc AKRO shares are trading higher after the company released preliminary topline week 96 results from HARMONY, a Phase 2b study of its lead product candidate efruxifermin (EFX) for pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), fibrosis stage 2 or 3 (F2-F3). 

The study previously met its primary endpoint of ≥1 stage improvement in fibrosis with no worsening of MASH after 24 weeks of treatment for both the 50mg EFX (41%) and 28mg EFX (39%) dose groups, compared to 20% for the placebo arm. 

At week 96, the response rates on this endpoint increased to 75% for 50mg EFX and 46% for 28mg EFX, compared to 24% for placebo.

The study also met additional histology endpoints at week 96—notably, 36% and 31% of patients treated with 50mg EFX and 28mg EFX experienced a 2-stage improvement in fibrosis without worsening of MASH—which is more than 10-fold the placebo rate of 3%. 

The placebo-adjusted effect size on fibrosis improvement without worsening of MASH more than doubled between week 24 and week 96 for the 50mg EFX group, with a slight increase observed for the 28mg EFX group. 

Specifically, the placebo-adjusted effect sizes for fibrosis improvement without worsening of MASH grew from 21% to 52% between week 24 and week 96 for 50mg EFX and from 20% to 22% for 28mg EFX. 

In a subset of patients at higher risk of progression to cirrhosis, 68% and 40% of the 50mg EFX and 28mg EFX groups, respectively, experienced at least a one-stage improvement in fibrosis without worsening of MASH, compared to 14% for placebo.

Analysis of the evolution of responses between weeks 24 and 96 indicated broader fibrosis improvement without worsening of MASH and sustained response, particularly at 50mg EFX. 

Among those patients with available week 96 biopsies whose fibrosis improved at week 24, 92% and 83% of the 50mg and 28mg EFX groups remained responders, respectively, compared to 40% for placebo.     

EFX was reported to be generally well-tolerated. There were no deaths. Fifteen serious adverse events were reported, generally balanced across dose groups.

In October 2023, Akero reported week 36 results for the SYMMETRY Phase 2b trial in patients with compensated cirrhosis (F4) due to MASH, Child-Pugh class A. Efruxifermin was not statistically significant in topping the placebo in improving liver scarring without worsening of NASH.

The SYMMETRY study was designed to include a second biopsy after 96 weeks of treatment, for which the results remain on track to be reported in the first quarter of 2025.

Price Action: AKRO shares are up 13.20% at $31.53 on the last check Monday.

Photo by Christina Victoria Craft on Unsplash