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Akero Therapeutics Presents Week 96 Results from Phase 2b SYMMETRY Clinical Trial of Efruxifermin in Patients with Compensated Cirrhosis Caused by MASH Showing Fibrosis Improvement without Worsening of MASH at the EASL Congress 2025
AkeroAkero(US:AKRO) Globenewswireยท2025-05-09 10:15

Core Insights - Akero Therapeutics presented promising results from the Phase 2b SYMMETRY trial for efruxifermin (EFX), indicating its potential to improve fibrosis in compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH) [1][2] Company Overview - Akero Therapeutics is a clinical-stage company focused on developing treatments for serious metabolic diseases with high unmet medical needs, particularly MASH [12] - Efruxifermin (EFX) is Akero's lead product candidate, currently undergoing evaluation in three ongoing Phase 3 studies [11][12] Clinical Trial Results - The SYMMETRY trial involved 182 patients with biopsy-confirmed compensated cirrhosis (F4) due to MASH, with 181 patients receiving EFX or placebo for 96 weeks [10] - At Week 96, 39% of patients treated with EFX 50mg showed fibrosis improvement compared to 15% in the placebo group (p=0.009) [2][3] - In the intent-to-treat (ITT) analysis, 29% of patients in the EFX 50mg group experienced fibrosis improvement versus 11% for placebo (p=0.031) [2][3] Efficacy and Safety - EFX demonstrated a significant increase in treatment effect over time, with a placebo-adjusted treatment effect doubling from 10% at Week 36 to 24% at Week 96 [5] - Non-invasive measures of liver fibrosis and injury, such as ELF test scores and liver stiffness by Fibroscan, showed continued improvement for the EFX 50mg group over 96 weeks [6] - The safety profile of EFX was consistent with previous trials, with mild to moderate gastrointestinal adverse events being the most common [8] Future Directions - Akero plans to continue evaluating EFX across all stages of MASH in the Phase 3 SYNCHRONY program [2] - The company aims to address the complex, multi-system disease state of MASH, including improvements in cardiovascular risk factors linked to the condition [11]