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Akebia Announces Successful Completion of Single Ascending Dose Phase 2a Pilot Study of AKB-6548 for Anemia

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Akebia Therapeutics, Inc., has announced that it has successfully completed a 28 day open label phase 2a dose escalation for AKB-6548 in stage 3 and 4 chronic kidney disease (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.

A controlled rise in hemoglobin and a corresponding decrease in ferritin was observed during the 28 day study. The compound was found to be safe and well tolerated, with no serious adverse events.

"In this study, all of the CKD patients saw a significant 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," said Dr. Robert Shalwitz, M.D., chief medical officer of Akebia.

"Our goal is to develop a more convenient, safer alternative to the injectable EPO products that are currently available. With this encouraging data in hand, we will shortly begin a larger multi-dose phase 2b study."

The phase 2a open label pilot study was designed to evaluate 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. Stage 3 CKD patients and stage 4 CKD patients were started at low dose of AKB-6548.

The dose was escalated and adjusted periodically according to a specific set of criteria. The efficacy of AKB-6548 was determined by measuring EPO, hemoglobin and other biomarkers including VEGF, hepcidin, transferrin and ferritin.