Akero Therapeutics, Inc., a company dedicated to developing groundbreaking treatments for severe
metabolic conditions with significant unmet needs, has announced upcoming presentations at the 75th Annual American Association for the
Study of Liver Diseases (AASLD) The Liver Meeting® 2024. The event is scheduled to be held from November 15-19, 2024, in San Diego. These presentations will focus on the results from the 96-week Phase 2b HARMONY study, which assesses the effectiveness and safety of Akero's leading product,
efruxifermin (EFX), in patients suffering from
pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), particularly those with fibrosis stages 2 or 3 (F2-F3). The study also integrates findings derived from AI and digital-based pathology analysis.
The first presentation is an oral presentation titled "Efruxifermin Significantly Improved
Liver Fibrosis at Week 96 in the HARMONY Study Across Subgroups and Improvements Were Associated With Changes in Biomarkers." Dr. Mazen Noureddin, a Professor of Medicine at Houston Methodist Hospital and Director of the Houston Research Institute, will present these findings on Sunday, November 17, 2024, from 2:00 PM to 2:15 PM PST. The oral session will focus on new therapies targeting MASLD and MASH.
Additionally, there will be two late-breaking poster presentations. The first poster, "Efruxifermin significantly reduced proportion of subjects with at-risk MASH and led to near-complete histological disease reversal at week 96 in the HARMONY study," will also be presented by Dr. Mazen Noureddin on Monday, November 18, 2024, from 8:00 AM to 5:00 PM PST. This session highlights significant reductions in the number of subjects with at-risk MASH and nearly complete histological disease reversal observed at the 96-week mark.
The second poster is titled "AI and digital-based pathology corroborate reduction in
fibrosis observed by conventional pathology with efruxifermin treatment of patients with F2-F3 MASH in the HARMONY study." This presentation, also set for Monday, November 18, 2024, from 8:00 AM to 5:00 PM PST, will focus on how AI and digital-based pathology confirm the reduction in fibrosis, observed through conventional methods, in patients treated with efruxifermin.
Akero Therapeutics is spearheading various clinical trials to advance treatments for metabolic diseases, particularly focusing on MASH. The company's leading product candidate, EFX, is currently being evaluated in the SYMMETRY study, a 96-week Phase 2b clinical trial targeting patients with compensated cirrhosis due to MASH (F4 fibrosis). Additionally, Akero is conducting three Phase 3 clinical trials: SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes, all exploring the effectiveness of EFX in patients with either pre-cirrhotic MASH or compensated cirrhosis due to MASH.
These SYNCHRONY trials are built upon the promising results from the Phase 2b HARMONY and SYMMETRY studies, where patients have been undergoing treatment for up to 96 weeks. These studies aim to provide robust data on the efficacy and safety of efruxifermin, potentially offering new hope for patients afflicted with these challenging conditions. Akero Therapeutics operates out of South San Francisco and continues to push the boundaries in developing transformative therapies for serious metabolic diseases.
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