Akebia Announces Positive Results From Vadadustat Alternative Dosing Study

(RTTNews) - Akebia Therapeutics Inc. (AKBA) announced positive results from FO2CUS, a study evaluating the efficacy and safety of vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, in hemodialysis patients who were converted from a long-acting erythropoiesis-stimulating agent to three times weekly oral vadadustat dosing for the maintenance treatment of anemia.

According to the company, the data demonstrated that vadadustat met the primary and secondary efficacy endpoints and was non-inferior to an erythropoiesis-stimulating agent or 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.

FO2CUS was an open-label, active-controlled, sponsor-blinded study that evaluated 456 hemodialysis patients who were randomized (1:1:1) into vadadustat 600mg, vadadustat 900mg, or a long-acting ESA (Mircera) treatment arms.

The primary efficacy endpoint was the mean change in hemoglobin 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).

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