Akero to showcase new analyses of Phase 2b HARMONY study at AASLD

Akero Therapeutics (AKRO) announced results of analyses supporting the clinical activity of efruxifermin in metabolic dysfunction-associated steatohepatitis in one oral presentation and two late-breaking poster presentations at the 75th Annual American Association for the Study of Liver Diseases The Liver Meeting, held November 15-19, 2024, in San Diego. “The data to be presented at The Liver Meeting show that 96 weeks of treatment with EFX has the potential to drive substantial reversal of disease in patients living with pre-cirrhotic MASH,” said Kitty Yale, chief development officer of Akero. “We are encouraged by consistent improvements observed across a number of clinically established markers of liver health and the corroboration of conventional histopathology assessments with Artificial Intelligence (AI)-based digital pathology. We believe these new analyses provide further evidence for the potential of EFX to be a differentiated therapy for MASH.” One poster presents an orthogonal analysis of baseline, week 24, and week 96 liver biopsies from HARMONY by HistoIndex. This analysis corroborates the pattern of anti-fibrotic effects observed with conventional pathology after treatment with EFX for 24 or 96 weeks. Specifically, a quantitative analysis by qFibrosis across different zones of the liver revealed EFX-associated reductions in fibrosis primarily in the perisinusoidal and periportal zones that were sustained or expanded from weeks 24 through 96 for participants, regardless of baseline fibrosis stage. The second poster presentation shows that 30% of participants receiving EFX 50mg for 96 weeks had almost complete reversal of MASH-related disease, as indicated by reversal of fibrosis to Fless than or equal to1, resolution of MASH, and normalization of liver fat content to less than or equal to5%, compared to 0% of participants on placebo. In addition, 100% of participants who received EFX 50mg for 96 weeks were categorized as “low risk of progressive MASH” by FibroScan-AST score. In contrast, 48% of participants receiving placebo remained at high or indeterminate risk of progressive MASH. Based on the same analyses, the extent of reversal of disease relative to placebo was smaller for participants receiving EFX 28mg than 50mg. “We believe that, taken together, the suite of presentations provides evidence supporting the consistent anti-fibrotic effects of EFX observed to date in the HARMONY trial as well as the the clinical activity and generally favorable safety profile of EFX in patients with precirrhotic MASH (F2-F3). The ongoing Phase 3 SYNCHRONY program is designed to confirm a favorable benefit-risk profile and support marketing applications for EFX for the treatment of MASH,” said Yale.