Akero Therapeutics Presents Poster and Late-breaking Oral Presentation on EFX at the EASL Congress 2024

Core Insights - Akero Therapeutics announced significant data from its lead product candidate efruxifermin (EFX) at the EASL Congress 2024, highlighting its potential in treating metabolic dysfunction-associated steatohepatitis (MASH) [1][7] Study Results - The Phase 2b HARMONY study demonstrated that EFX met its primary endpoint, showing ≥1-stage improvement in fibrosis after 24 weeks for both 50 mg (41%, p<0.05) and 28 mg (39%, p<0.05) dose groups, compared to 20% for placebo [2] - At Week 96, response rates for fibrosis improvement increased to 75% (p<0.001) for the 50 mg group and 46% (p=0.07) for the 28 mg group, versus 24% for placebo [2] - The study also reported that 36% (p<0.01) and 31% (p<0.01) of patients in the 50 mg and 28 mg groups, respectively, achieved a 2-stage improvement in fibrosis without worsening of MASH, significantly higher than the placebo rate of 3% [3] Treatment Efficacy - EFX treatment showed sustained and expanded treatment response over 96 weeks, with over 80% of EFX-treated patients maintaining improved fibrosis from Week 24 to Week 96 [4] - Among non-responders at Week 24, 63% of patients treated with 50 mg EFX experienced improvement in fibrosis by Week 96, compared to a placebo rate of 21% [4] - The results indicate EFX was well tolerated, with no liver injury or decompensation events reported [4] Biomarker Analysis - A post-hoc analysis revealed significant changes in key biomarkers associated with collagen synthesis and degradation, indicating EFX's effects on extracellular matrix remodeling in the liver [5] - EFX treatment led to decreased interstitial collagens and regeneration of structural collagens, correlating with reductions in liver injury markers [5] Company Overview - Akero Therapeutics is focused on developing treatments for serious metabolic diseases, including MASH, with EFX being evaluated in multiple ongoing clinical trials [12] - MASH affects over 17 million Americans and is a leading cause of liver transplants and cancer in the US and Europe [11]