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news.Akebia Therapeutics has started patient dosing in AKB-6548 single dose Phase 2a clinical trial. AKB-6548 is an orally bioavailable hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) in development for anemia.
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Akebia is expected to recruit up to 28 patients in AKB-6548 Phase 2a study, to assess the safety, tolerability and pharmacokinetics of a single dose of AKB-6548 in stage 3 and 4 chronic kidney disease patients. The study is expected to be completed by January 2011.
In addition, the efficacy of AKB-6548 will be ascertained by measuring EPO and other biomarker responses including VEGF, hepcidin, transferrin and ferritin.
Joseph Gardner, president and CEO of Akebia, said: “We recently successfully completed Phase 1 studies, and are pleased to now begin testing AKB-6548 in patients with late-stage kidney disease seeking treatment for anemia.
“Patients with chronic kidney disease often suffer from anemia, and the current treatment approach involves injectable products to increase a patient’s level of EPO. AKB-6548 is an orally bioavailable product designed to naturally increase EPO, and we believe it will offer many advantages over current approaches including safety, dosing convenience and cost-effectiveness.”