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news.Akebia Therapeutics (Akebia) has initiated dosing for a Phase 1b multi-dose clinical trial of AKB-6548, an orally bioavailable hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) in development for anemia.
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The Phase 1a study of AKB-6548 has demonstrated a dose-related increase in erythropoietin with no significant adverse events.
Akebia said that the Phase 1b study is designed to evaluate the safety, tolerability and pharmacokinetics of three ascending series of doses of AKB-6548 in healthy volunteers. In the study the volunteers will be dosed with AKB-6548 once daily for ten days.
In addition, the efficacy of AKB-6548 is expected to be ascertained by measuring erythropoietin and other biomarker responses including VEGF, hepcidin, transferrin and ferritin. The trial will involve approximately 33 healthy volunteers and will be conducted at Medpace, in Cincinnati, OH. The study is expected to be completed by mid-2010.
In early January, Akebia has reported the successful completion of the first-in-man Phase 1a study for AKB-6548 in healthy volunteers. In the clinical study, a single dose of AKB-6548 increased EPO levels and was found to be safe and well tolerated.
Joseph Gardner, president and CEO of Akebia, said: “We are pleased to be rapidly moving AKB-6548 into Phase 1b studies following the successful completion of the Phase 1a trial. In this next study we will continue to monitor the safety profile of AKB-6548 as well as erythropoietin and other biomarkers in a multi-dose setting.
“We are excited about the potential of this compound, and that early results have supported our goal of providing patients with a product that offers unique advantages over current approaches to address anemia including simple oral dosing, and an improved safety profile.”