Akero Therapeutics announces publication of Phase 2b SYMMETRY trial

Akero Therapeutics (AKRO) announced publication of results from the Phase 2b SYMMETRY trial in the New England Journal of Medicine. The publication reports results from the 96-week SYMMETRY study evaluating the efficacy and safety of Akero’s lead FGF21 analog efruxifermin, in participants with biopsy-confirmed compensated cirrhosis, Child-Pugh Class A, caused by metabolic dysfunction-associated steatohepatitis. The primary endpoint was greater than or equal to1-stage fibrosis improvement without MASH worsening at 36 weeks of treatment, with secondary outcomes of fibrosis improvement without MASH worsening at week 96 and MASH resolution at weeks 36 and 96. Using an intent-to-treat analysis of the 36 week results, for which participants with missing biopsies were included as non-responders, 19% of participants in the EFX 50mg group and 18% of participants in the EFX 28mg group met the primary endpoint, compared to 13% for placebo. At week 96, using the same ITT analysis, 29% of participants in the EFX 50mg group and 21% of participants in the EFX 28mg group had fibrosis improvement without MASH worsening, compared to 11% in the placebo group. Most participants in the EFX groups with a fibrosis improvement at week 36 appeared to maintain their response at week 96, with additional new responders observed at week 96, particularly for the EFX 50mg group. EFX was also associated with improvements in noninvasive markers of liver injury and fibrosis, as well as markers of insulin sensitivity and lipid metabolism compared with placebo at week 96. The safety and tolerability of EFX observed in the SYMMETRY trial was consistent with previous trials. Observed adverse events, more common with EFX than placebo, were primarily gastrointestinal or injection site related, with the majority being mild or moderate and transient in nature.