Akero Therapeutics Begins Phase 3 SYNCHRONY Outcomes Study for Efruxifermin in MASH Patients with Compensated Cirrhosis

Akero Therapeutics, Inc., a company focused on developing groundbreaking treatments for serious metabolic diseases, has announced the dosing of the first patient in its Phase 3 SYNCHRONY Outcomes trial. This study aims to assess the effectiveness and safety of Efruxifermin (EFX) in treating compensated cirrhosis, specifically fibrosis stage 4 (F4), due to metabolic dysfunction-associated steatohepatitis (MASH).

Kitty Yale, the chief development officer at Akero, emphasized the significance of this milestone, noting the urgent need for treatments to delay or prevent liver failure in MASH patients. Yale expressed optimism about EFX's potential to address various stages of disease progression. The company aims to advance the clinical development of EFX as a promising treatment for liver fibrosis, cirrhosis, and metabolic dysregulation.

The SYNCHRONY Outcomes trial is a part of Akero’s comprehensive Phase 3 SYNCHRONY program. This program also includes two other ongoing, randomized, placebo-controlled trials, which started enrolling patients in late 2023. One of these trials, SYNCHRONY Histology, is examining the efficacy and safety of EFX in patients with biopsy-confirmed pre-cirrhotic MASH (F2-F3). The other, SYNCHRONY Real-World, is evaluating the safety and tolerability of EFX in patients with non-invasively diagnosed MASH or metabolic dysfunction-associated steatotic liver disease (MASLD) (F1-F4).

The SYNCHRONY program aims to assess improvements in fibrosis and resolution of MASH, along with liver-related long-term clinical outcomes and overall mortality rates. The findings from these trials could potentially support marketing applications for treating both pre-cirrhotic liver fibrosis and compensated cirrhosis due to MASH.

In these Phase 3 studies, patients self-administer EFX using the LyoJect 3S dual chamber syringe, a pre-filled device designed for commercial use if EFX is approved for marketing. Additionally, results from the ongoing Phase 2b SYMMETRY study, which is evaluating EFX in patients with compensated cirrhosis due to MASH (F4), are expected in early 2025.

Efruxifermin (EFX) is Akero’s leading product candidate for MASH. It is a differentiated Fc-FGF21 fusion protein engineered to mimic the balanced biological activity of native FGF21, a hormone that alleviates cellular stress and regulates metabolism. EFX has shown potential in reducing liver fat and inflammation, reversing fibrosis, increasing insulin sensitivity, and improving lipid metabolism. This comprehensive approach addresses the complex, multi-system nature of MASH, including improvements in lipoprotein risk factors associated with cardiovascular disease, which is the leading cause of death in MASH patients. EFX offers the convenience of once-weekly dosing and has been generally well-tolerated in clinical trials so far.

MASH, a severe form of MASLD, affects over 17 million Americans. It is characterized by an excessive accumulation of fat in the liver, which causes stress and injury to liver cells, leading to inflammation and fibrosis. This condition 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.

Akero Therapeutics, headquartered in South San Francisco, is committed to developing transformative treatments for patients with serious metabolic diseases, including MASH. Their lead product candidate, EFX, is being evaluated in the ongoing SYMMETRY study, a 96-week Phase 2b clinical trial in patients with compensated cirrhosis due to MASH (F4 fibrosis), as well as three ongoing Phase 3 clinical trials: SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes. These trials build on the results of two Phase 2b clinical studies, HARMONY and SYMMETRY, in which patients have been treated for up to 96 weeks.