Akero Therapeutics Presents Analyses of Phase 2b HARMONY Study at the 2023 International Liver Congress Reinforcing and Characterizing EFX-Related Improvements in Liver Histopathology

Data show changes in non-invasive tests in EFX-treated patients were associated with improvements in NASH histopathology and highlight dose-dependent responses

SOUTH SAN FRANCISCO, Calif., June 23, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today announced two presentations of secondary and post-hoc analyses of the Phase 2b HARMONY study of efruxifermin (EFX) in patients with pre-cirrhotic nonalcoholic steatohepatitis (NASH), fibrosis stage 2 or 3 (F2-F3). The posters are being presented at the 2023 International Liver Congress today and tomorrow and will be available on Akero’s website.

“We continue to be really pleased with the consistency of clinical response associated with EFX treatment across four independently conducted Phase 2 studies,” said Tim Rolph, chief scientific officer of Akero. “The new analyses not only expand on previously reported results, but also indicate non-invasive testing could be used to monitor clinical response to EFX in a real-world setting where liver biopsies are a barrier to diagnosis of NASH and assessment of treatment-related effects.”

“Noninvasive tests of liver injury, inflammation and fibrosis are improved by efruxifermin and correlate with histological improvements in patients with F2-F3 NASH: secondary analysis of Ph2b HARMONY study” (Poster TOP-091, Abstract 1669) was selected as a Top Poster (“among the best in its category”) and is being displayed in a dedicated area of the Congress.

• Results of non-invasive tests performed as part of the HARMONY study were correlated with EFX-related changes in liver histopathology after 24 weeks of treatment.
• The poster shows that EFX-associated changes in non-invasive tests were associated with improvements in NASH histopathology. Normalization of liver fat content and markers of liver injury, AST or ALT, was associated with higher probability of resolving histopathologic features of steatohepatitis and fibrosis after 24 weeks of treatment with EFX.
• These results indicate non-invasive tests could be used to monitor and predict responses to treatment with EFX among patients with F2-F3 fibrosis and NASH.