Business
Akebia Therapeutics Announces Top-Line Results from its PRO2TECT Global Phase 3 Program of Vadadustat for Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients Not on Dialysis
- PRO2TECT achieves primary and key secondary efficacy endpoints - PRO2TECT does not meet primary safety MACE endpoint - Company believes totality of data
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"- PRO2TECT achieves primary and key secondary efficacy endpoints\n - PRO2TECT does not meet primary safety MACE endpoint\n - Company believes totality of data from global Phase 3 program (PRO2TECT and INNO2VATE) supports NDA submission for both non-dialysis and dialysis indications\n - Company remains on track to submit NDA\n - Conference call today at 8:30 a.m. ET\n\n\nCAMBRIDGE, 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. \n\n \n \n \n \n \n \n\n \nVadadustat achieved the primary and key secondary efficacy endpoint in each of the two PRO2TECT studies, demonstrating non-inferiority (NI) 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 did not meet the primary safety endpoint of the PRO2TECT 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, and non-fatal stroke across both PRO2TECT studies. \nAkebia is working to present the full dataset from its global Phase 3 program (INNO2VATE and PRO2TECT) at an upcoming medical conference and publish the data in peer reviewed journals. Akebia plans to submit to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for vadadustat for the treatment of anemia due to CKD in adult dialysis-dependent and non-dialysis dependent patients as early as possible in 2021. Akebia and its collabo...