Benzinga - by Vandana Singh, Benzinga Editor.
Akero Therapeutics Inc (NASDAQ: AKRO) reported a 36-week analysis of SYMMETRY, a 96-week Phase 2b study of efruxifermin (EFX) in patients with compensated cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH).
Efruxifermin was not statistically significant in topping the placebo in improving liver scarring without worsening of NASH, resulting in shares tumbling.
A trend was observed for the primary endpoint of fibrosis (scarring) improvement at 36 weeks, with 22% and 24% of the 28mg (p-value of 0.38) and 50mg (p-value of 0.28) EFX-treated groups, respectively, experiencing at least a one-stage improvement in liver fibrosis and no worsening of NASH, compared with 14% for placebo.
In addition, 4% of patients in each of the EFX-treated groups experienced a three- or two-stage fibrosis improvement without worsening of NASH — from compensated cirrhosis (F4) to F1 or F2, compared with 0% for placebo.
Statistically significant rates of NASH resolution in 63% and 60% of patients at week 36 were observed for the 28mg and 50mg EFX-treated groups, respectively, compared with 26% for placebo.
Statistically significant improvements were also observed for both EFX groups in non-invasive liver injury and fibrosis markers, insulin sensitization, and lipoproteins.
EFX was reported to be generally well-tolerated. Diarrhea, nausea, increased appetite, and injection site erythema were the most frequent treatment-emergent adverse events related to the drug.
Price Action: AKRO shares are down 56.3% at $21.20 during the premarket session on the last check Tuesday.
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