Akero Therapeutics, Inc. (Nasdaq: AKRO) announced the dosing of the first patient in the Phase 3 SYNCHRONY Outcomes trial. This study will assess the efficacy and safety of Efruxifermin (EFX) in treating compensated cirrhosis, fibrosis stage 4 (F4), resulting from metabolic dysfunction-associated steatohepatitis (MASH).
The SYNCHRONY Outcomes trial is a crucial component 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. The SYNCHRONY Histology trial is evaluating the efficacy and safety of EFX in patients with biopsy-confirmed pre-cirrhotic MASH (F2-F3), while the SYNCHRONY Real-World trial is assessing the safety and tolerability of EFX in patients with non-invasively diagnosed MASH or metabolic dysfunction-associated steatotic liver disease (MASLD) (F1-F4).
Evaluating Efficacy and Safety
The SYNCHRONY program aims to evaluate the extent of improvement in fibrosis and resolution of MASH, as well as liver-related long-term clinical outcomes and all-cause mortality. The data generated has the potential to support marketing applications for the treatment of both pre-cirrhotic liver fibrosis and compensated cirrhosis due to MASH.
Kitty Yale, chief development officer of Akero, stated, “Dosing the first patient in the SYNCHRONY Outcomes trial is an exciting milestone that rounds out our Phase 3 SYNCHRONY program evaluating EFX in patients with varied levels of MASH severity. There continues to be a substantial unmet need for treatments that delay or prevent liver failure among patients with MASH, and the SYNCHRONY program has the potential to show that treatment with EFX can do so in different stages of disease progression.”
About Efruxifermin (EFX)
Efruxifermin (EFX) is Akero’s lead product candidate for MASH, a differentiated Fc-FGF21 fusion protein engineered to mimic the balanced biological activity profile of native FGF21. This endogenous hormone alleviates cellular stress and regulates metabolism throughout the body. EFX has demonstrated the ability to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity, and improve lipid metabolism. This comprehensive approach has the potential to address the complex, multi-system nature of MASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death in MASH patients. EFX is designed for convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date.
MASH: A Growing Concern
MASH is a severe form of MASLD, estimated to affect over 17 million Americans. It is characterized by excessive fat accumulation in the liver, causing stress and injury to liver cells, leading to inflammation and fibrosis. This can progress to cirrhosis, liver failure, cancer, and eventually death. MASH is the fastest-growing cause of liver transplants and liver cancer in the US and Europe.
Ongoing Studies
Patients in all Phase 3 studies self-administer EFX using the LyoJect 3S dual-chamber syringe, a pre-filled device intended for commercial use if 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 (F4), are anticipated in the first quarter of 2025.
