Akero Therapeutics, Inc. reported patients have received their first doses of efruxifermin (EFX) in the SYNCHRONY Phase 3 program. Two parallel, randomized, placebo-controlled trials have commenced: SYNCHRONY Histology evaluating the efficacy and safety of EFX in patients with biopsy-confirmed pre-cirrhotic nonalcoholic steatohepatitis/metabolic dysfunction- associated steatohepatitis (NASH/MASH), and SYNCHRONY Real-World assessing safety and tolerability of EFX in patients with non-invasively diagnosed NASH/MASH or non-alcoholic fatty liver disease/metabolic dysfunction-associated steatotic liver disease (NAFLD/MASLD). In all EFX Phase 3 studies, patients will self-administer EFX using the LyoJect 3S dual chamber syringe, a pre-filled device intended for commercial use in the event EFX is approved for marketing.

This optimized formulation delivers blood levels of EFX comparable to those of the liquid formulation used in prior clinical studies. An FDA Type B, End-of-Phase-2 meeting has been scheduled for the first quarter of 2024 to review the design of the planned SYNCHRONY Outcomes study evaluating EFX in the treatment of NASH/MASH patients with compensated cirrhosis (F4). SYNCHRONY Outcomes, as proposed to FDA, will evaluate regression of fibrosis based on histology, with the potential to support applications for accelerated and conditional approval in the United States and Europe, respectively, and follow patients with cirrhosis for long-term clinical outcomes to support full approval.

All week 96 visits for the Phase 2b HARMONY study, evaluating EFX for the treatment of pre-cirrhotic NASH/MASH (F2-F3), have been completed. EFX is designed to offer convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date.