Akero Therapeutics reports results from Phase 2b SYMMETRY trial

Akero Therapeutics (AKRO) presented results from the Phase 2b SYMMETRY trial demonstrating the potential of efruxifermin, or EFX, to improve fibrosis in compensated cirrhosis, or F4, caused by metabolic dysfunction-associated steatohepatitis, or MASH, in a late-breaking oral presentation at the European Association for the Study of the Liver Congress 2025 taking place May 7-10, in Amsterdam, the Netherlands. Week 96 data presented from SYMMETRY, a Phase 2b trial evaluating the efficacy and safety of Akero’s lead product candidate, EFX, in patients with biopsy-confirmed compensated cirrhosis (F4) due to MASH, showed fibrosis reduction without MASH worsening by both completer and intent-to-treat, or ITT, analyses after 96 weeks. In the pre-specified analysis of patients with baseline and week 96 biopsies, 39% of patients treated with EFX 50mg had fibrosis improvement compared to 15% of placebo-treated patients. In the ITT population, with missing week 96 biopsies treated as non-responders, 29% of patients in the EFX 50mg group experienced this improvement, compared to 11% for placebo. The primary endpoint of the SYMMETRY study was greater than or equal to1 stage fibrosis improvement with no worsening of MASH at Week 36. A numerical improvement was observed in the EFX groups vs. placebo at Week 36 but the differences were not statistically significant. Comparison of the proportion of patients with a fibrosis reduction at Week 36 and Week 96 in the pre-specified analysis of patients with baseline and week 96 biopsies, showed more than a doubling of placebo-adjusted treatment effect for the EFX 50mg group, from 10% to 24%. This increase in effect size shows the importance of longer treatment with EFX for patients with compensated cirrhosis as compared to responses observed in trials of EFX in patients with earlier stage fibrosis. The larger treatment effect observed after 96 weeks is corroborated by changes in noninvasive measures of liver fibrosis and injury. For example, two key non-invasive measures of the extent of fibrosis development in the whole liver, ELF test score and liver stiffness by Fibroscan, showed continuing improvement over 96 weeks for the 50mg EFX group.