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news.Akebia Therapeutics has concluded an open label Phase 2a dose escalation study of AKB-6548 in stage 3 and 4 chronic kidney disease (CKD) patients.
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The study was intended to investigate the safety, tolerability and pharmacokinetics of 28 days of repeat oral doses of AKB-6548 in a cohort of stage 3 and stage 4 CKD patients.
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 anemic patients.
The company expects to start a larger multi-dose Phase 2b study soon.
Akebia chief medical officer Robert Shalwitz said in this study, all of the CKD patients saw a increase in hemoglobin levels while taking AKB-6548.
"Additionally, we saw no significant increase in the compound’s half life in this group of renally compromised patients which supports the once-daily, oral dosing regimen," Shalwitz said.
"Our goal is to develop a more convenient, safer alternative to the injectable EPO products that are currently available."