Key Takeaways
•Akero Therapeutics’ efruxifermin (EFX) demonstrated significant histological improvements in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in the Phase 2b HARMONY study.
•After 96 weeks, 75% of patients receiving 50mg EFX achieved at least a one-stage improvement in fibrosis without worsening of MASH, compared to 24% in the placebo group.
•These results suggest EFX’s potential as a transformative treatment for patients with serious metabolic diseases.
Akero Therapeutics announced preliminary topline results from its Phase 2b HARMONY study, evaluating efruxifermin (EFX) in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), with fibrosis stages 2 or 3. The study previously met its primary endpoint at week 24, demonstrating that both 50mg and 28mg doses of EFX led to significant improvements in liver fibrosis without worsening of MASH. Â
At week 96, the efficacy of EFX was further evident. In the 50mg EFX group, 75% of patients achieved at least a one-stage improvement in fibrosis without worsening of MASH, compared to 24% in the placebo group. The 28mg EFX group also showed improvement, with 46% of patients meeting the same criteria. These findings underscore EFX’s potential to reverse liver fibrosis in patients with pre-cirrhotic MASH. Â
Dr. Andrew Cheng, President and CEO of Akero, highlighted the significance of these results, stating that the data support EFX’s potential as a transformative treatment for patients with serious metabolic diseases. He emphasized the company’s commitment to advancing EFX through further clinical development to address the unmet needs of patients with MASH. Â
Patients with pre-cirrhotic MASH
The HARMONY study is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of EFX in patients with pre-cirrhotic MASH. Participants were randomized to receive weekly subcutaneous injections of 50mg EFX, 28mg EFX, or placebo. The primary endpoint was the proportion of patients achieving at least a one-stage improvement in fibrosis without worsening of MASH at week 24, with secondary endpoints including safety and tolerability assessments. Â
Efruxifermin is an Fc-FGF21 fusion protein engineered to mimic the biological activity of native fibroblast growth factor 21 (FGF21), a hormone that regulates metabolism and reduces liver fat. EFX is designed to offer convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date. Â
Akero plans to present detailed results from the HARMONY study at upcoming scientific conferences and in peer-reviewed publications. The company is also preparing for Phase 3 clinical trials to further evaluate EFX’s efficacy and safety in a larger patient population. Â
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