Akero Therapeutics is developing pioneering medicines designed to restore metabolic balance and halt NASH progression.
EFX mimics the biological activity of FGF21 to address an array of causes and pathological processes underlying development of NASH.
In the recently completed main portion of the BALANCED Phase 2a trial of EFX in NASH patients, those treated with efruxifermin demonstrated statistically significant improvements in all key drivers of disease. Those on efruxifermin experienced reductions in absolute and relative liver fat and in levels of the enzyme ALT, which is a validated marker of liver damage. In addition, of the 40 treatment responders who had end-of-treatment biopsies after only 16 weeks of treatment, 48% achieved at least a one-stage improvement in fibrosis without worsening of NASH, and 48% achieved NASH resolution with no worsening of fibrosis. The magnitude of improvement in histological parameters of NASH was among the highest observed to date across the NASH field. Those in the treatment arm also experienced clinically meaningful improvements in glycemic control, including HbA1C levels, as well as healthier lipid profiles and weight loss.