On Monday, Akero Therapeutics, Inc. (NASDAQ: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).

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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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