CINCINNATI, OH—Akebia Therapeutics, Inc., a pharmaceutical discovery and development company focused on anemia and vascular disorders, today announced that it has successfully completed a randomized, double-blinded, placebo-controlled Phase 2 dose-ranging study of AKB-6548 in patients with stage 3 and 4 chronic kidney disease (CKD).
AKB-6548 is an orally bioavailable hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor designed to increase the natural production of erythropoietin (EPO) and cause a controlled, gradual rise in hemoglobin in patients with anemia. The study met its primary endpoint of a dose-responsive increase in hemoglobin from baseline over the 42 days of the study (p<0.0001).
"Safe, effective, oral therapies for patients that suffer from anemia associated with chronic kidney disease represents a major unmet need. The results from this Phase 2 study demonstrate AKB-6548’s ability to safely and effectively increase hemoglobin levels in a controlled manner, which recapitulates results seen in our prior pilot dose escalation study. We have also identified an optimal dose to take into a larger Phase 2b study, preparations for which are underway,” said Dr. Robert Shalwitz, SVP and Chief Medical Officer of Akebia. “We believe AKB-6548 could offer patients a treatment option that mimics the body’s natural response to hypoxia, including erythropoietin production in a highly controllable manner and a well-coordinated iron response. These are key attributes that are unavailable with today’s standard of care.”
The Phase 2 randomized, double-blind, placebo-controlled dose range finding study was designed to evaluate the safety, tolerability and pharmacokinetics of AKB-6548 in patients with stage 3 and 4 CKD. Subjects were randomized into 5 different dosing groups, and AKB-6548 was administered orally on an outpatient basis once daily for 42 days. The study enrolled 93 subjects at multiple sites in the United States.