Phase 2b Results Expected in Q4 2014
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
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
"Anemia associated with CKD remains a serious and under-treated public
health risk, associated with higher rates of morbidity and mortality,"
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.
AKB-6548 is a once-daily, oral therapy currently in development for the treatment of anemia secondary to chronic kidney disease (CKD). AKB-6548 is designed to achieve a meaningful and sustained increase in red blood cell production and iron utilization that is similar to the body's natural 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 hypoxia-inducible factor (HIF), the primary regulator of this response to hypoxia. AKB-6548 is currently in Phase 2b development for the treatment of anemia secondary to CKD in patients who are not dependent on dialysis, and plans are underway to expand clinical development with a Phase 2 study in the dialysis population. AKB-6548 is being developed as an important alternative to injectable erythropoiesis-stimulating agents (ESAs), which are associated with a higher risk for increased mortality and adverse cardiovascular events, must be injected intravenously or subcutaneously, and often require supplemental administration of iron. As a potential best-in-class HIF-PH inhibitor, AKB-6548 is designed to improve hemoglobin levels, reduce the need for IV or oral iron supplementation and offer a differentiated safety profile with the convenience of once-daily, oral therapy.
This press release includes forward-looking statements. Such
forward-looking statements include those about Akebia's strategy, future
plans and prospects, including statements regarding the development plan
for AKB-6548, the design of Akebia's clinical trials, the potential
indications and benefits of AKB-6548, and the expected timing for the
announcement of clinical trial data. The words "anticipate," "appear,"
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subject to risks and uncertainties that could cause actual results to
differ materially from those expressed or implied in such statement,
including the risk that existing preclinical and clinical data may not
be predictive of the results of ongoing or later clinical trials; the
actual time it takes to complete clinical trials and analyze the data;
the ability of Akebia to successfully complete the clinical development
of AKB-6548 or any other product candidate; the funding required to
develop Akebia's product candidates; the content and timing of decisions
Senior Vice President, Chief Financial Officer
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