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news.Akebia Therapeutics has completed a Phase II dose-ranging study of AKB-6548 in patients with stage 3 and 4 chronic kidney disease (CKD).
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The randomized, double-blinded, placebo-controlled study met its primary endpoint of a dose-responsive increase in hemoglobin from baseline over the 42 days of the study (p<0.0001).
The results show a significant, dose-responsive increase in hemoglobin and overall red blood cell production, the company said.
AKB-6548 was generally well tolerated, with no dose-related changes in adverse events, liver function or renal function as compared to placebo.
The orally bioavailable hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor is designed to increase the natural production of erythropoietin (EPO) and cause a controlled, gradual rise in hemoglobin in patients with anemia.
Akebia SVP and chief medical officer Robert Shalwitz said: "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."