Akebia Therapeutics, Inc, a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, announced positive top-line results from FO2CUS, a study evaluating the efficacy and safety of vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, in hemodialysis patients who were converted from a long-acting erythropoiesis-stimulating agent (ESA) to three times weekly oral vadadustat dosing for the maintenance treatment of anemia.
The data demonstrated that vadadustat met the primary and secondary efficacy endpoints and was non-inferior to an ESA in the treatment of anemia due to chronic kidney disease in patients on hemodialysis when used three times a week at the time of dialysis and with a comparable safety profile to the current standard of care.
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FO2CUS was an open-label, active-controlled, sponsor-blinded study that evaluated 456 hemodialysis patients who were randomized into vadadustat 600mg, vadadustat 900mg, or a long-acting ESA treatment arms. The primary efficacy endpoint was the mean change in hemoglobin (Hb) between baseline and the primary evaluation period (weeks 20-26). The secondary efficacy endpoint was the mean change in Hb between baseline and the secondary evaluation period (weeks 46-52).
“The FO2CUS study demonstrated that vadadustat managed hemoglobin levels in patients on hemodialysis when administered three times a week, which we believe is important as the dosing schedule aligns with dialysis visits and has the potential, if approved, to provide an oral alternative to the standard of care,” said Steven K. Burke, M.D., Senior Vice President, Research & Development and Chief Medical Officer of Akebia. “We continue to believe in the potential benefit vadadustat could deliver to patients on dialysis if approved and recognize that even with available treatments many dialysis patients do not stay within target hemoglobin range.
The FO2CUS study has been a tremendous undertaking, and we’re pleased the data support that vadadustat was non-inferior to, and had a comparable safety profile to, an ESA. We would like to extend our sincere appreciation to everyone involved in this study including the patients, physicians, investigators, and site coordinators.”
SOURCE: PR Newswire