Akero Therapeutics presents analyses of Phase 2b HARMONY study

Akero Therapeutics announced two presentations of secondary and post-hoc analyses of the Phase 2b HARMONY study of efruxifermin in patients with pre-cirrhotic nonalcoholic steatohepatitis, fibrosis stage 2 or 3. “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” was selected as a Top Poster 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. “Characterization of the Patterns of Resolution of Histopathology After Efruxifermin Treatment of Patients with NASH Fibrosis for 24 Weeks” was selected for presentation during the poster tour. It will be summarized by Akero’s vice president of clinical research and medical affairs, Reshma Shringarpure, between 15.30-16.15 CET as part of the Metabolism, Alcohol and Toxicity track hub on June 24th. The post-hoc semi-quantitative analysis characterized changes in liver histopathology through the evaluation of steatosis-activity-fibrosis and SAF-Activity scores. Improvements in SAF and SAF-A scores following treatment with EFX corroborated the already reported improvement in NASH-CRN fibrosis stage and substantial resolution of steatohepatitis. Post-hoc qualitative analyses investigated histological features associated with fibrosis regression by comparing post-treatment with pre-treatment biopsies. The comparison revealed intra-grade and intra-stage improvements which were not detected by categorical staging as a scoring system for histologic features of regression. These orthogonal post-hoc analyses provided evidence of a progressive dose-dependent response to EFX.