Akero Therapeutics announces first patient dosed in Phase 3 SYNCHRONY study

Akero Therapeutics reported the first patient was dosed in the Phase 3 SYNCHRONY Outcomes trial. The study will evaluate the efficacy and safety of EFX for the treatment of compensated cirrhosis, fibrosis stage 4, due to metabolic dysfunction-associated steatohepatitis. Outcomes is part of Akero’s broader SYNCHRONY Phase 3 program, which includes two other ongoing, randomized, placebo-controlled trials that began enrolling patients in the fourth quarter of 2023. SYNCHRONY Histology is evaluating the efficacy and safety of EFX in patients with biopsy-confirmed pre-cirrhotic MASH, while SYNCHRONY Real-World, is assessing the safety and tolerability of EFX in patients with non-invasively diagnosed MASH or metabolic dysfunction-associated steatotic liver disease. The SYNCHRONY program is evaluating extent of improvement in fibrosis and resolution of MASH, as well as liver-related long-term clinical outcomes and all cause mortality, with the potential to support marketing applications for treatment of both pre-cirrhotic liver fibrosis and compensated cirrhosis due to MASH. In all Phase 3 studies, patients are self-administering EFX using the LyoJect 3S dual chamber syringe, a pre-filled device intended for commercial use in the event EFX is approved for marketing. Week 96 results from the ongoing Phase 2b SYMMETRY study, evaluating the efficacy and safety of EFX in patients with compensated cirrhosis due to MASH, are anticipated in the first quarter of 2025.