Akero Therapeutics Inc AKRO reported a 36-week evaluation of SYMMETRY, a 96-week Part 2b research of efruxifermin (EFX) in sufferers with compensated cirrhosis (F4) because of nonalcoholic steatohepatitis (NASH).
Efruxifermin was not statistically vital in topping the placebo in enhancing liver scarring with out worsening of NASH, leading to shares tumbling.
A pattern was noticed for the first endpoint of fibrosis (scarring) enchancment at 36 weeks, with 22% and 24% of the 28mg (p-value of 0.38) and 50mg (p-value of 0.28) EFX-treated teams, respectively, experiencing not less than a one-stage enchancment in liver fibrosis and no worsening of NASH, in contrast with 14% for placebo.
As well as, 4% of sufferers in every of the EFX-treated teams skilled a three- or two-stage fibrosis enchancment with out worsening of NASH — from compensated cirrhosis (F4) to F1 or F2, in contrast with 0% for placebo.
Statistically vital charges of NASH decision in 63% and 60% of sufferers at week 36 have been noticed for the 28mg and 50mg EFX-treated teams, respectively, in contrast with 26% for placebo.
Statistically vital enhancements have been additionally noticed for each EFX teams in non-invasive liver damage and fibrosis markers, insulin sensitization, and lipoproteins.
EFX was reported to be usually well-tolerated. Diarrhea, nausea, elevated urge for food, and injection web site erythema have been essentially the most frequent treatment-emergent antagonistic occasions associated to the drug.
Worth Motion: AKRO shares are down 56.3% at $21.20 through the premarket session on the final verify Tuesday.
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