Akero Therapeutics: Reversing Compensated Cirrhosis with Efruxifermin in MASH Patients
In a groundbreaking development, Akero Therapeutics, a clinical-stage biotech company, announced significant findings from their Phase 2b SYMMETRY study. The study reported an unprecedented, statistically significant reversal of compensated cirrhosis (F4) in patients with MASH (Massive Alcoholic Steatohepatitis) after 96 weeks of treatment with efruxifermin (EFX).
What is MASH and Compensated Cirrhosis?
MASH is a severe form of alcoholic liver disease characterized by inflammation and fibrosis in the liver, leading to liver damage and cirrhosis. Compensated cirrhosis is a stage in the progression of cirrhosis where the liver can still maintain normal or near-normal function, but it is not a cure. It can lead to decompensated cirrhosis, which is life-threatening.
The SYMMETRY Study and Efruxifermin
The SYMMETRY study, a randomized, double-blind, placebo-controlled Phase 2b study, enrolled 133 patients with biopsy-confirmed MASH. Participants were randomly assigned to receive either EFX or a placebo, along with standard of care. The primary endpoint was the proportion of patients with a greater than 1-point improvement in the fibrosis stage at Week 96.
The results showed that 37% of EFX-treated patients achieved this primary endpoint, compared to 13% in the placebo group. Additionally, there was a significant reduction in the proportion of patients with a worsening fibrosis stage in the EFX group (14%) versus the placebo group (33%).
The SYNCHRONY Real-World Study
Akero also announced the completion of enrollment in the double-blinded portion of the Phase 3 SYNCHRONY Real-World Study. This study aims to evaluate EFX in patients with MASLD (Mild-to-Moderate Alcoholic Steatohepatitis) and MASH. The results from this study are expected to provide further insights into the safety and efficacy of EFX in real-world settings.
New Analyses from HARMONY Study
At the 75th Annual AASLD The Liver Meeting® 2025, new analyses from the Phase 2b HARMONY study were presented. These analyses focused on patients with pre-cirrhotic (F2-F3) MASH. The study showed that EFX treatment led to significant reductions in liver enzymes and inflammatory markers, suggesting potential benefits for earlier-stage MASH patients.
Impact on Patients and the World
For individuals with MASH and cirrhosis, these findings offer hope for a potential treatment that can halt or even reverse liver damage. This could lead to improved quality of life and reduced risk of complications, such as liver failure and liver cancer.
On a larger scale, these results could significantly impact the healthcare system, as alcoholic liver disease is a major cause of morbidity and mortality worldwide. Effective treatments for MASH and cirrhosis could reduce healthcare costs and save lives.
Conclusion
Akero Therapeutics’ findings from the SYMMETRY study represent a significant step forward in the treatment of MASH and compensated cirrhosis. The completion of the SYNCHRONY Real-World Study and presentation of new HARMONY study analyses further underscore the potential of efruxifermin as a transformative treatment for patients with serious metabolic diseases. These developments offer hope for improved patient outcomes and a potential reduction in the burden of alcoholic liver disease on the healthcare system.
- Akero Therapeutics reported significant findings from their Phase 2b SYMMETRY study, showing an unprecedented, statistically significant reversal of compensated cirrhosis (F4) in MASH patients after 96 weeks of treatment with efruxifermin (EFX).
- The SYNCHRONY Real-World Study, a Phase 3 study evaluating EFX in patients with MASLD or MASH, has completed enrollment in its double-blinded portion.
- New analyses from the Phase 2b HARMONY study, presented at The Liver Meeting® 2025, showed potential benefits of EFX for patients with pre-cirrhotic (F2-F3) MASH.
- These developments offer hope for improved patient outcomes and a potential reduction in the burden of alcoholic liver disease on the healthcare system.
