Benzinga | Sep 3, 2020 07:07AM EDT

Akebia Therapeutics Announces Top-Line Results From PRO2TECT Global Phase 3 Program Of Vadadustat; Achieved Primary And Key Secondary Efficacy Endpoint, Did Not Meet Primary Safety MACE Endpoint

- PRO2TECT achieves primary and key secondary efficacy endpoints

- PRO2TECT does not meet primary safety MACE endpoint

- Company believes totality of data from global Phase 3 program (PRO2TECT and INNO2VATE) supports NDA submission for both non-dialysis and dialysis indications

- Company remains on track to submit NDA

- Conference call today at 8:30 a.m. ET

CAMBRIDGE, Mass., Sept. 3, 2020 /PRNewswire/ -- Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announces top-line results from PRO2TECT, the second of its two global Phase 3 cardiovascular outcomes programs. The two PRO2TECT 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 not on dialysis. The Company's vadadustat development program also includes two other global Phase 3 studies (INNO2VATE) for the treatment of anemia due to CKD in adult patients on dialysis, for which the Company reported positive top-line data in May.