Akero Announces Strongly Positive Histological Data Across All Efruxifermin Dose Groups in 16-Week Phase 2a BALANCED Study in NASH Patients

48% fibrosis improvement of at least one stage without worsening of NAS across all dose groups, with a 62% response rate for the 50mg dose group
28% fibrosis improvement of at least two stages across all dose groups, with a 38% response rate for the 50mg dose group
48% NASH resolution without worsening of fibrosis across all dose groups, with a 54% response rate for the 50mg dose group

SOUTH SAN FRANCISCO, Calif., June 30, 2020 /PRNewswire/ — Akero Therapeutics, Inc. (Nasdaq: AKRO) today announced results of a 16-week analysis of secondary and exploratory endpoints in its Phase 2a BALANCED study of efruxifermin (EFX), formerly known as AKR-001, in patients with nonalcoholic steatohepatitis (NASH). Notably, of the 40 treatment responders who had end-of-treatment biopsies, we observed that 48% achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score (NAS) and 28% achieved at least a two-stage improvement in fibrosis. In addition, 48% of responders achieved NASH resolution with no worsening of fibrosis. Improvements in glycemic control and dyslipidemia, as well as weight loss, were also observed across all dose groups. Treatment with EFX was generally reported to be well tolerated.

“These substantial improvements observed in multiple measures of liver health, particularly the one- and two-stage improvements in fibrosis, are extremely encouraging and among the strongest biopsy results reported in NASH to date,” said Stephen Harrison, M.D., medical director of Pinnacle Clinical Research. “I believe Efruxifermin continues to set itself apart as one of the most promising drug candidates in NASH, with impressive histology results after just 16 weeks of treatment.”