Akebia Therapeutics Announces Full Enrollment of its Global Phase 3 Program of Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease

Akebia Therapeutics, Inc. (Nasdaq: AKBA) today announced full enrollment of its global Phase 3 program evaluating the safety and efficacy of vadadustat for the treatment of anemia due to chronic kidney disease (CKD). Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) in global Phase 3 development for the treatment of anemia due to CKD in dialysis dependent (DD)-CKD patients and non-dialysis dependent (NDD)-CKD patients. The Company’s global Phase 3 vadadustat program consists of the INNO₂VATE studies which were fully enrolled in April 2019 with 3,923 DD-CKD patients, and the PRO₂TECT studies which are now fully enrolled with 3,513 NDD-CKD patients.

The INNO₂VATE and PRO₂TECT studies are large, randomized, open-label, non-inferiority design studies that are assessing the safety and efficacy of vadadustat versus an active comparator, darbepoetin alfa, an injectable erythropoiesis-stimulating agent (ESA). The primary efficacy endpoint of these studies is a change in hemoglobin (Hb) from baseline, and the primary safety endpoint is an assessment of cardiovascular safety as measured by major adverse cardiovascular events (MACE), defined as all-cause mortality, non-fatal myocardial infarction and non-fatal stroke. Other safety endpoints being assessed include individual MACE components, thromboembolic events, hospitalization for heart failure, and Hb excursions. Other efficacy endpoints being assessed include time in range (Hb), intravenous iron use and CKD progression. The Company continues to expect to report top-line results from INNO₂VATE in Q2 2020 and PRO₂TECT in mid-2020, subject to the accrual of MACE.

“We have tremendous confidence in the global Phase 3 program that we've designed for vadadustat and believe we are well positioned for clinical, regulatory and commercial success. Importantly, our program includes multiple secondary efficacy and safety endpoints to assess both clinically and commercially important areas of differentiation between vadadustat and the current standard of care, ESAs,” said John P. Butler, President and Chief Executive Officer of Akebia. “If successful with our program, we expect vadadustat to be the first HIF-PHI in the U.S. and EU markets with data directly comparing its outcomes to the current standard of care in both DD and NDD patients. We believe these data will be extremely relevant for physicians, patients and payers as they make important care decisions.”