Akebia Initiates INNO2VATE Phase 3 Program for Vadadustat in Dialysis Patients With Anemia Related to Chronic Kidney Disease
-- Company's Phase 3 PRO2
"The launch of the INNO2VATE program represents an important milestone for our global vadadustat Phase 3 program," stated John P. Butler, President and Chief Executive Officer of Akebia. "Similar to our parallel Phase 3 PRO2TECT program in patients who are not currently on dialysis, INNO2VATE is designed to demonstrate the best-in-class potential of vadadustat to treat patients who are suffering from anemia related to chronic kidney disease."
The INNO2VATE program includes two separate studies and will collectively enroll approximately 2,600 dialysis-dependent patients with anemia related to chronic kidney disease. Both studies will include a 1:1 randomization and an open label, active-control, non-inferiority design. Primary endpoints include an efficacy assessment of the hemoglobin response and an assessment of cardiovascular safety as measured by standard major adverse cardiovascular events (MACE) criteria. The INNO2VATE-Correction study will evaluate patients not currently being treated with recombinant erythropoiesis stimulating agents (rESAs). The INNO2VATE-Conversion study will evaluate patients currently receiving rESA who will be converted to either vadadustat or the active control, with the goal of maintaining their baseline hemoglobin levels.
Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer with best-in-class potential for the treatment of anemia related to chronic kidney disease. Vadadustat, currently in development, exploits the same mechanism of action used by the body to naturally adapt to lower oxygen availability associated with a moderate increase in altitude. At higher altitudes, the body responds to lower oxygen availability with increased production of HIF, which coordinates the interdependent processes of iron mobilization and erythropoietin production to increase red blood cell production and, ultimately, improve oxygen delivery.
About Anemia Related to Chronic Kidney Disease
Approximately 30 million people in the
This press release includes forward-looking statements. Such forward-looking statements include those about Akebia's strategy, future plans and prospects, including statements regarding the potential indications and benefits of vadadustat and the plans for the INNO2VATE and PRO2TECT Phase 3 programs. The words "anticipate," "appear," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; the ability of Akebia to successfully complete the clinical development of vadadustat; the funding required to develop Akebia's product candidates and operate the company, and the actual expenses associated therewith; the cost of the Phase 3 studies of vadadustat and the availability of financing to cover such costs; the timing and content of decisions made by the
AJ Gosselin, 617-844-6130
Manager, Corporate Communications
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