Akebia Announces Manuscript Highlighting Global Phase 3 INNO2VATE Program Rationale, Study Design and Baseline Characteristics Published in Peer-Reviewed Medical Journal
CAMBRIDGE, Mass., Nov. 16, 2020 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the publication of a manuscript detailing the study design and methodology for its global Phase 3 INNO2VATE program in Nephrology Dialysis Transplantation (NDT), the official journal for the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA). The publication of Akebia's manuscript in NDT marks the first publication in a peer-reviewed journal related to a global Phase 3 program of an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) being evaluated as a potential treatment for anemia due to chronic kidney disease (CKD).
The manuscript, titled "Global Phase 3 programme of vadadustat for treatment of anaemia of chronic kidney disease: rationale, study design and baseline characteristics of dialysis-dependent patients in the INNO2VATE trials," includes a detailed description of design and methodology of the two Phase 3 INNO2VATE trials and summarize demographic and baseline characteristics of randomized patients. Importantly, the manuscript notes that "demographics and baseline characteristics of patients enrolled in the two studies are comparable to those typically observed in patients with DD (dialysis dependent)-CKD, suggesting the results of the INNO2VATE studies will be generalizable to a large proportion of the DD-CKD population."
INNO2VATE evaluated the efficacy and safety of vadadustat, Akebia's investigational oral HIF-PHI, versus darbepoetin alfa for the treatment of anemia due to CKD in adult patients on dialysis. As previously reported, vadadustat achieved the primary and key secondary efficacy endpoints and the primary safety endpoint of the INNO2VATE program, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of a major adverse cardiovascular event (MACE), which is the composite of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke across both INNO2VATE studies. In addition, vadadustat achieved non-inferiority to darbepoetin alfa on key secondary safety endpoints that included expanded MACE, cardiovascular MACE, cardiovascular mortality, and all-cause mortality.
"Achieving the first publication of a manuscript on the design of our global Phase 3 program focused on a HIF-PHI for anemia in a well-regarded, peer-reviewed nephrology journal is an important achievement for our company," said Steven K. Burke, M.D., Senior Vice President, Research & Development and Chief Medical Officer of Akebia Therapeutics. "We believe publication of the manuscript reinforces the clinical rigor that guided the development of our INNO2VATE program, which has since successfully produced clear and consistent results. Our medical team continues to support vadadustat's potential with a comprehensive publication plan that is expected to yield additional peer-reviewed publications this year and next year."
Nephrology Dialysis Transplantation: an international basic science and clinical renal journal (NDT) is the leading nephrology journal in Europe and renowned worldwide, devoted to original clinical and laboratory research in nephrology, dialysis and transplantation. NDT is an official journal of the ERA-EDTA. Published monthly, the journal provides an essential resource for researchers and clinicians throughout the world. All research articles in the journal have undergone peer review.
About Akebia Therapeutics
About Anemia due to Chronic Kidney Disease (CKD)
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Company Codes: NASDAQ-NMS:AKBA