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Akebia Therapeutics completes enrollment in its Phase IIb clinical study of AKB-6548

Akebia Therapeutics, a biopharmaceutical company, has completed enrollment in its ongoing 200-patient Phase IIb study of AKB-6548 for the treatment of anemia associated with chronic kidney disease (CKD) in patients who are not dependent on dialysis.

AKB-6548, a once-daily, oral investigational therapy, is designed to achieve a coordinated and natural increase in red blood cell production and iron utilization that is similar to the body’s adaptive response to hypoxia, or low oxygen levels, resulting from modest increases in altitude.

AKB-6548 acts by inhibiting the hypoxia-inducible factor prolyl hydroxylase (HIF-PH) enzyme, leading to stabilization and increased levels of HIF, the primary regulator of this response to hypoxia.

Akebia president and CEO John P Butler noted that the company is on track to execute its strategy to develop a convenient, oral therapy with the potential to provide patients a predictable, meaningful and sustained improvement in their hemoglobin levels.

"The completion of enrollment in our Phase 2b study for AKB-6548 is an important milestone for Akebia, and we are working to develop a clinical data package that can position AKB-6548 as the best-in-class new therapy for the treatment of anemia secondary to CKD," Butler added.

The Phase IIb randomized, double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of AKB-6548 for the treatment of anemia associated with CKD in patients who are not on dialysis.

There are 209 patients enrolled in the study at more than 50 sites across the United States. The primary purpose of this study is to demonstrate an adaptive approach to dosing AKB-6548 that will enable subjects to appropriately raise their hemoglobin levels from baseline without excessive excursions to greater than 13.0g/dL.

Akebia expects to announce results from the Phase IIb study in the fourth quarter of 2014.