Akebia Therapeutics, Inc., has announced that it has initiated dosing in patients for a phase 2a dose ranging study of 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.
In a recently completed phase 2a dose escalation study, a controlled rise in hemoglobin and a corresponding decrease in ferritin were observed.
"This study represents an important step in the clinical pathway we have designed for AKB-6548, and we expect it will once again demonstrate the compound's ability to safely and effectively increase hemogloblin levels in a controlled manner, as well as help identify optimal dosing levels," said Joseph Gardner, Ph.D., president and chief executive officer of Akebia.
Gardner continued, "Patients with CKD are often undertreated for anemia, and there is a clear need for a new therapy that is safer and easier to use than the currently available injectable products."
The phase 2a randomized, double-blind, placebo-controlled dose range finding study is designed to evaluate the safety, tolerability and pharmacokinetics of AKB-6548 in stage 3 and 4 CKD patients, and will enable the selection of a dose regimen to be used in future studies.
Subjects will be randomized into five different dosing groups, and AKB-6548 will be administered orally on an outpatient basis once daily for 42 days. The study will enroll 100 subjects at multiple sites in the United States.