By Chris Wack
Akero Therapeutics shares were up 21% at $33.77 after the company said it saw positive preliminary topline week-96 results from a Phase 2b study evaluating the efficacy and safety of its lead product candidate, efruxifermin, in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis, fibrosis stage 2 or 3.
The stock hit its low of $11.25 on Oct. 27, and is down 29% in the past 12 months.
The clinical-stage company said 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 efruxifermin and 28mg efruxifermin dose groups, compared with 20% for the placebo arm.
For people who have MASH, fatty tissue builds up on the liver, and eventually causes damage known as fibrosis.
After 24 weeks, 41% and 39% of the high-dose and low-dose groups, respectively, showed improvement in fibrosis with no worsening in MASH symptoms. At week 96, the response rates on this endpoint increased to 75% for 50mg EFX and 46% for 28mg EFX, compared with 24% for placebo.
The study also met additional histology endpoints at week 96, including 36% and 31% of patients treated with 50mg efruxifermin and 28mg efruxifermin experienced a 2-stage improvement in fibrosis without worsening of MASH, is more than 10-fold the placebo rate of 3%.
Eefruxifermin was reported to be generally well tolerated. There were no deaths. Fifteen serious adverse events were reported, which were generally balanced across dose groups. The 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.
Write to Chris Wack at chris.wack@wsj.com
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