Akebia completes enrollment in ongoing 200-patient Phase 2b study of AKB-6548

Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on the development of novel proprietary therapeutics based on hypoxia-inducible factor (HIF) biology and the commercialization of these products for patients with kidney disease, today announced it has completed enrollment in its ongoing 200-patient Phase 2b study of AKB-6548 for the treatment of anemia associated with chronic kidney disease (CKD) in patients who are not dependent on dialysis.

AKB-6548, a once-daily, oral investigational therapy, is designed to achieve a coordinated and natural increase in red blood cell production and iron utilization that is similar to the body's adaptive response to hypoxia, or low oxygen levels, resulting from modest increases in altitude. AKB-6548 acts by inhibiting the hypoxia-inducible factor prolyl hydroxylase (HIF-PH) enzyme, leading to stabilization and increased levels of HIF, the primary regulator of this response to hypoxia.

"We are on track to execute our strategy to develop a convenient, oral therapy with the potential to provide patients a predictable, meaningful and sustained improvement in their hemoglobin levels," said John P. Butler, President and Chief Executive Officer of Akebia. "The completion of enrollment in our Phase 2b study for AKB-6548 is an important milestone for Akebia, and we are working to develop a clinical data package that can position AKB-6548 as the best-in-class new therapy for the treatment of anemia secondary to CKD."

The Phase 2b randomized, double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of AKB-6548 for the treatment of anemia associated with CKD in patients who are not on dialysis. There are 209 patients enrolled in the study at more than 50 sites across the United States. The primary purpose of this study is to demonstrate an adaptive approach to dosing AKB-6548 that will enable subjects to appropriately raise their hemoglobin levels from baseline without excessive excursions to greater than 13.0 g/dL.

"Anemia associated with CKD remains a serious and under-treated public health risk, associated with higher rates of morbidity and mortality," said Robert Shalwitz, Chief Medical Officer of Akebia. "The well-established risks associated with injectable erythropoiesis-stimulating agents have greatly curtailed their use, creating an urgent need for an alternative for combating anemia that can safely and significantly increase hemoglobin levels in CKD patients with anemia."

Anemia associated with CKD affects about 1.8 million people in the U.S. The current standard of care, injectable erythropoiesis-stimulation agents (ESAs), induces the body to produce red blood cells using supra-physiological levels of erythropoietin-receptor agonists usually in conjunction with supplemental administration of iron. AKB-6548, by contrast, has the potential to provide a more predictable and sustained level of improvement in hemoglobin levels while avoiding the rapid spikes in erythropoietin levels that are commonly seen with ESAs.

Akebia expects to announce results from the Phase 2b study in the fourth quarter of 2014.