Global leadership in hypoxia inducible factor (HIF) biology. Dedicated to advancing care for serious disease.
Pursuing advances across multiple disease states.
We were founded in 2007 to discover and develop novel therapeutic solutions leveraging hypoxia inducible factor—or HIF—biology, a primary regulator involved in multiple major biological pathways.
Our strategy is to develop novel therapeutics for patients based on the biology of HIF and to commercialize products for patients with kidney disease, beginning with vadadustat (also known as AKB-6548) for patients with anemia secondary to chronic kidney disease (CKD). We intend to:
Complete the development of vadadustat for anemia secondary to CKD.
We announced positive top-line results from our Phase 2 studies in patients with anemia secondary to dialysis-dependent CKD (DD-CKD) and non–dialysis-dependent CKD (NDD-CKD). Following the successful End-of-Phase 2 discussions with US and European regulatory agencies, we launched our Phase 3 program known as PRO2TECT in the NDD-CKD population in December 2015. We recently announced that Akebia has reached alignment with both the US Food and Drug Administration and the European Medicines Agency regarding key elements in the Phase 3 INNO2VATE DD-CKD program and we launched the program in August 2016.
Obtain regulatory approval of vadadustat for anemia secondary to CKD in the United States, Europe, and other markets.
We launched a Phase 3 program known as PRO2TECT in the non–dialysis-dependent CKD (NDD-CKD) population in December 2015, and we initiated a parallel Phase 3 program known as INNO2VATE in the dialysis-dependent CKD (DD-CKD) population in August 2016. The Phase 3 programs are designed to support regulatory approvals in major markets worldwide and to collect data required to establish a new standard of care of the treatment of anemia.
Commercialize vadadustat in the United States and seek partnerships in other territories.
We will establish a specialty sales and marketing organization to commercialize vadadustat in the United States.
Continue to develop vadadustat for further indications.
We have completed Phase 2 clinical development for the treatment of patients with anemia secondary to dialysis-dependent CKD (DD-CKD) and non–dialysis-dependent CKD (NDD-CKD), the two indications we are currently pursuing.
Advance pipeline assets.
We plan to advance AKB-6899, a second HIF prolyl hydroxylase (HIF-PH) inhibitor product candidate, which we believe, based on preclinical testing, has the ability to increase erythropoietin (EPO) levels while reducing vascular endothelial growth factor, or VEGF, levels. We intend to file an Investigational New Drug, or IND, application in 2015.
Acquire or in-license additional nephrology products.
If we are able to successfully launch vadadustat, we will look to leverage our commercial infrastructure with additional products that would be prescribed by nephrologists.
We own worldwide rights to our HIF-based product candidates, including vadadustat, and may enter into strategic collaborations to fully realize all of the elements of our strategy.