Research & Development Services
Tenacity: At Akebia, we are inspired to think boldly and move bold thinking into action. We leverage our scientific expertise and this innovative thinking to develop clinical advances in areas that are important to people living with kidney disease. We thrive as collaborators because we believe that we can go further together. We work with partners across the globe to pioneer and grow new areas of research and development. We are optimistic and want to have a positive impact. Each day we bring our drive to life with the work we do.
Why Anemia?
Anemia is a condition in which a person does not have enough healthy red blood cells to carry adequate oxygen to the body’s tissues. It can commonly occur in people with chronic kidney disease (CKD) because their kidneys do not produce enough erythropoietin (EPO), which is a hormone released into the blood to help regulate the production of red blood cells. Anemia affects approximately 5.7 million people with CKD in the U.S. alone. Left untreated, anemia deteriorates patient health and is associated with increased morbidity and mortality in people with CKD.
Injectable erythropoiesis-stimulating agents (ESAs) have been the standard of care for treating anemia due to CKD in both dialysis dependent and non-dialysis dependent patients since the early 1990s. While there are treatment options, unmet needs remain and undertreatment continues to be a challenge.
We believe new treatment options for anemia are not only needed, but also possible. Here at Akebia, we are leading a change by working to advance innovative therapies to better the lives of people living with kidney disease.
Innovating to Protect the Kidneys
Our lead product candidate, vadadustat, is part of a new class of investigational agents called oral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), which are based on Nobel Prize-winning science. HIF-PHIs are designed to mimic the body’s response to lower levels of oxygen, such as when a person is at high altitude. The body naturally responds to lower oxygen levels by increasing the availability of HIF, which is a protein that coordinates the expression of the genes responsible for erythropoietin synthesis and the regulation of iron metabolism. Inhibition of hypoxia-inducible factor prolyl hydroxylase (HIF-PH) can lead to increased red blood cell production and improved oxygen delivery to tissues. The discovery of HIF has laid the foundation to help understand the central role of oxygen sensing in many diseases, including anemia due to CKD.
Within Japan, VafseoTM (vadadustat) is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.
Clinical Development
Vadadustat is an oral HIF-PHI that was studied for the treatment of anemia due to CKD in dialysis dependent and non-dialysis dependent adult patients.
Anemia due to CKD and Beyond
Leveraging our HIF expertise, we are focused on the development of vadadustat for the treatment of anemia due to CKD and are working to identify and initiate development planning for other programs where vadadustat may have therapeutic benefits. We also aim to add to our pipeline and portfolio of novel therapeutics through internal discovery and development, and through strategic transactions, such as in-licenses, collabroations and acquisitions. In addition, given our expertise in research and development, we believe there may be opportunities to leverage these assets and establish mutually beneficial relationships with other companies that are looking to enter the renal market or attempting to develop renal therapeutics.
Vadadustat is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority for use outside of Japan.
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