Key Takeaways
•Akero Therapeutics has completed enrollment of 601 patients in the double-blind portion of its Phase 3 SYNCHRONY Real-World study, evaluating efruxifermin (EFX) in patients with metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD).
•The SYNCHRONY Real-World study aims to assess the safety and tolerability of EFX, with results anticipated in the first half of 2026.
•Efruxifermin is designed to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity, and improve lipoproteins, potentially addressing the complex disease state of MASH.
Akero Therapeutics has successfully enrolled 601 patients in the double-blind portion of its Phase 3 SYNCHRONY Real-World study, evaluating efruxifermin (EFX) in individuals diagnosed with metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD). Initiated in November 2023, the study achieved this enrollment milestone in just over a year.
The SYNCHRONY Real-World study is a randomized, double-blind, placebo-controlled trial designed to assess the safety and tolerability of EFX in patients with fibrosis stages F1 through F4. Participants receive once-weekly subcutaneous doses of either 50mg EFX or placebo over a 52-week period. Primary endpoints focus on evaluating the safety profile of EFX, while secondary endpoints include changes in non-invasive markers of liver fibrosis and injury, lipoprotein levels, glycemic control, and body weight.
Phase 3 Trial of Efruxifermin Reaches Key Milestone
Efruxifermin is Akero’s lead product candidate for MASH, engineered to mimic the biological activity of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism. EFX aims to reduce liver fat and inflammation, reverse fibrosis, enhance insulin sensitivity, and improve lipid profiles, addressing the multifaceted nature of MASH. The drug is designed for convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date.
MASH is a severe form of MASLD, affecting over 17 million Americans. Characterized by excessive fat accumulation in the liver, MASH leads to cellular stress, inflammation, and fibrosis, potentially progressing to cirrhosis, liver failure, or cancer. Currently, there are no approved treatments for MASH, which is a leading cause of liver transplants and liver cancer in the United States and Europe.
Akero’s Chief Development Officer, Kitty Yale, highlighted the rapid enrollment as indicative of the significant need for effective MASH treatments and the growing enthusiasm surrounding EFX’s development. She noted that previous Phase 2 studies demonstrated improvements in liver histology and non-invasive markers of liver health. The company anticipates reporting results from the SYNCHRONY Real-World study, marking its first Phase 3 data, in the first half of 2026.
In addition to the SYNCHRONY Real-World study, Akero is conducting other Phase 3 trials, including SYNCHRONY Histology and SYNCHRONY Outcomes, to further evaluate the efficacy and safety of EFX in patients with varying stages of MASH. These studies build upon the promising results observed in earlier trials, aiming to establish EFX as a potential leading treatment option for this underserved patient population.
This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.
