Zinger Key Points
- Akero's 50mg EFX led to a 24% effect size for cirrhosis reversal over placebo in week 96 biopsies, highlighting treatment potential.
- Non-GLP-1 subgroup saw 45% cirrhosis reversal with EFX, showing benefits are independent of GLP-1 therapy.
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On Monday, Akero Therapeutics, Inc. AKRO released preliminary topline week 96 results from SYMMETRY Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, due to metabolic dysfunction-associated steatohepatitis (MASH).
Among patients with baseline and week 96 biopsies (n=134), 39% of patients treated with 50mg EFX (n=46) experienced reversal of cirrhosis with no worsening of MASH, representing a 24% effect size over placebo at 15% (n=47).
In the Intent to Treat (ITT) population (n=181), with all missing week 96 biopsies treated as failures, 29% of patients in the 50mg EFX group (n=63) experienced reversal of cirrhosis with no worsening of MASH, representing a 17% effect size over placebo at 12% (n=61).
With more than a doubling of effect size from weeks 36 to 96 in the 50mg group (from 10% to 24%), the SYMMETRY study underscores the benefit of longer EFX treatment for patients with compensated cirrhosis (F4).
In a subgroup of patients with baseline and week 96 biopsies who were not taking GLP-1 at baseline (n=97), 45% in the 50mg EFX group experienced a reversal of cirrhosis with no worsening of MASH (n=29) compared to 17% for placebo (n=36), suggesting that the observed reversal of cirrhosis was not attributable to GLP-1 therapy.
Improvements in noninvasive liver fibrosis and injury measures support the reversal of cirrhosis.
EFX was reported to be generally well-tolerated. There were no deaths on EFX, but one in the placebo arm due to pneumonia.
Across both EFX groups, the most frequent adverse events (AEs) were grade 1 or 2, gastrointestinal in origin (diarrhea, nausea, and increased appetite), and transient in nature.
In October 2024, Akero Therapeutics reported a 36-week analysis of the SYMMETRY study of efruxifermin.
Efruxifermin was not statistically significant in topping the placebo in improving liver scarring without worsening of NASH.
Price Action: At last check on Monday, AKRO stock was up 112.5% at $55.60 during the premarket session.
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