CAMBRIDGE, Mass., May 5, 2020 /PRNewswire/ — Akebia Therapeutics, Inc. ^[1](Nasdaq: AKBA^[2]), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced positive top-line results from INNO₂VATE, the first of its two global Phase 3 cardiovascular outcomes programs. The two INNO₂VATE studies evaluated the efficacy and safety of vadadustat, Akebia’s investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), versus darbepoetin alfa for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.

Vadadustat achieved the primary and key secondary efficacy endpoint in each of the two INNO₂VATE studies, demonstrating non-inferiority to darbepoetin alfa as measured by a mean change in hemoglobin (Hb) between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52). Vadadustat also achieved the primary safety endpoint of the INNO₂VATE program, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of major adverse cardiovascular events (MACE), which is the composite of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke across both INNO₂VATE studies. Each analysis was measured against non-inferiority (NI) margins agreed upon with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

“The INNO₂VATE study results are very compelling,” stated Glenn Chertow, M.D., M.P.H., Professor of Medicine, Chief, Division of Nephrology at Stanford University, and Co-Chair of the independent Executive Steering Committee for INNO₂VATE. “The greatest strength of the INNO₂VATE data is the consistency across both efficacy and all MACE components. The nephrology community has been eagerly awaiting straightforward, high-quality data evaluating the treatment of anemia due to CKD with a novel HIF-PHI. Based on these two randomized trials comparing vadadustat to the active darbepoetin control, I am confident that vadadustat has the potential to be a safe and effective option for the treatment of anemia due to CKD in adult patients requiring dialysis, upon approval.”