Our multi-modal drug, efruxifermin (EFX), mimics FGF21 to confront the many facets of NASH, and clinical data suggest it has the potential to be a foundational NASH monotherapy.
Results of our BALANCED Phase 2a study showed statistically significant improvement in all key drivers of disease. Patients on EFX experienced reductions in liver fat for all three tested doses of EFX compared to placebo. In addition, in an exploratory analysis after 16 weeks of treatment, 48% of treatment responders who had end-of-treatment biopsies showed at least a one-stage improvement in fibrosis without worsening of NAFLD activity score, 28% achieved at least a two-stage improvement in fibrosis, and 48% achieved NASH resolution without worsening of fibrosis. Patients on drug also experienced improvements in glycemic control, as well as healthier lipid profiles and weight loss.
These results point to the potential for EFX to be a foundational monotherapy for the treatment of NASH.