Akebia Therapeutics (AKBA) Reports Publication of Strong Vadadustat Phase 2 Data in CKD-Related Anemia

September 19, 2016 8:43 AM EDT

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Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced the publication of positive results from a Phase 2b study of vadadustat, a once-daily oral HIF stabilizer, in development for the treatment of anemia related to chronic kidney disease (CKD). The study demonstrated that vadadustat increased and maintained hemoglobin levels in patients throughout the 20-week study in a predictable and controlled manner. The peer-reviewed paper, titled “Vadadustat, a novel oral HIF stabilizer, provides effective anemia treatment in non-dialysis-dependent chronic kidney disease,” was published online by Kidney International, the official journal of the International Society of Nephrology.

“Treatment of anemia related to CKD with the current standard of care, erythropoiesis-stimulating agents, can lead to substantial hemoglobin increases above the desired target range,” said Pablo Pergola, M.D., Ph.D., Renal Associates PA, and University of Texas Health Science Center at San Antonio. “These results demonstrate that vadadustat raised and maintained hemoglobin levels while minimizing hemoglobin excursions and improving iron mobilization, and may offer patients an effective alternative therapy for treating renal anemia.”

The multicenter, randomized, double-blind, placebo-controlled study assessed the ability of oral, once-daily vadadustat to correct anemia in patients with stages 3a-5 non-dialysis dependent chronic kidney disease. Patients initiated treatment with either 450 mg of vadadustat or matching placebo, administered once daily for 20 weeks. The initial 450 mg daily dose of vadadustat was adjusted in accordance with the patient's hemoglobin (Hb) response using a dose titration algorithm designed to minimize Hb excursions above 13.0 g/dL. Patients were assigned to one of three study groups: recombinant erythropoietin stimulating agents (rESAs) treatment naïve, rESAs previously treated, or rESAs actively treated. Within each group, patients were randomized 2:1 to receive vadadustat or placebo and were stratified according to CKD stage and the presence or absence of diabetes mellitus. The full manuscript is available on the Kidney International website at: http://www.kidney-international.org/article/S0085-2538(16)30357-X/fulltext.

Findings from the study include:

  • Vadadustat increased and maintained Hb levels in patients throughout the study when compared to placebo; by week two, mean Hb levels in the vadadustat group had increased significantly compared to placebo, plateaued by week six to week eight and were sustained throughout the 20 weeks of treatment, with limited Hb excursions and dose adjustments;
  • Vadadustat improved iron mobilization compared to the placebo group, as measured by significant decreases in hepcidin and ferritin, as well as a significant increase in total iron binding capacity; and
  • There was no difference between the vadadustat and placebo groups in the mean change from baseline in vascular endothelial growth factor (VEGF) levels at week 12 or end of treatment.

Vadadustat was generally well tolerated in the Phase 2b trial and overall adverse events were balanced between the treatment and placebo groups.

“The positive results from our Phase 2b study provided a strong foundation for our vadadustat global Phase 3 program, which continues to enroll dialysis-dependent and non-dialysis patients with anemia related to chronic kidney disease,” said Brad Maroni, M.D., Chief Medical Officer at Akebia. “We will continue to publish the results from the more than 15 clinical studies of vadadustat, and look forward to reporting key findings from our Phase 3 program following the completion of those trials.”



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