Akebia Says Vadadustat Non Inferior To Standard Care In Alternative Dosing Study In Anemia Patients On Dialysis

Akebia Therapeutics Inc AKBA announced topline results from the FO2CUS study evaluating the efficacy and safety of vadadustat in hemodialysis patients 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 with a similar safety profile to the current standard of care.
FO2CUS was an open-label, active-controlled, sponsor-blinded study that evaluated 456 hemodialysis patients.
In the FO2CUS study, each vadadustat dosing regimen (600mg, 900mg) and the combined vadadustat-treated group achieved the primary efficacy endpoint of the mean change in Hb between baseline and the primary evaluation period compared to Mircera in adult patients on hemodialysis, demonstrating non-inferiority to Mircera based on a non-inferiority margin of -0.75 g/dL.
Similarly, each dosing regimen of vadadustat and the combined vadadustat-treated group achieved the secondary efficacy endpoint of the mean change in Hb between baseline and the secondary evaluation period.
Akebia expects to present full study results at an upcoming medical conference or in a peer-reviewed journal this year.
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