Development Program
For patients with declining kidney function, iron deficiency anemia is a significant problem that is often under-diagnosed and undertreated 1,2. To improve the quality of care for pre-dialysis renal anemia patients, Palkion’s development program is focused on developing and identifying HIF-prolyl hydroxylase domain (PHD) inhibitors, which elevate the endogenous production of erythropoietin (EPO), leading to the production of red blood cells. As an oral agent, this new treatment option has the potential to be as effective as current injectable forms of EPO, while offering greater safety and convenience. Palkion is moving its lead compound, PN-3602, toward the clinic, while continuing to develop an ongoing back-up program.
Opportunity
In the United States alone, 1.1 million people suffer from anemia associated with declining kidney function. The current treatment involves regular injections with recombinant erythropoiesis stimulating agents (ESAs). The $10 billion global market for ESAs includes $1.3 billion spent each year to treat anemic pre-dialysis patients in the United States. Yet today, approximately 75 percent of these patients remain untreated.
Approximately 800,000 anemic pre-dialysis patients remain untreated in the United States.
While generally regarded as safe and effective, current injectable products face a number of issues, including the cost of therapy, patient inconvenience, hypersensitivity reactions and balancing the inability to dose titrate long-acting erythropoiesis stimulating agents (ESAs) against the high-frequency injections of short-acting ESAs. In addition, current treatments must be stored refrigerated and are administered intravenously or subcutaneously, usually in conjunction with dialysis. In addition, bolus injections result in widely varying hemoglobin levels, and either high EPO or hemoglobin levels may contribute to increased mortality and morbidity.
Palkion Solution
Anemic pre-dialysis patients represent an underserved market that could benefit greatly from an effective, more convenient and economic treatment option. At Palkion, we believe physicians may consider an oral treatment for both pre-dialysis renal anemia patients and patients for whom subcutaneous injection is not feasible. To address this unmet need, Palkion is developing an oral agent that is well-differentiated from recombinant and peptide-based EPO products, due to its ease of administration, convenient room storage, lower price and more physiologic mechanism of action.
1 Fishbane S, Pollack S, Feldman HI, Joffe MM. Iron indices in chronic kidney disease in the National Health and Nutritional Examination Survey 1988-2004. Clin J Am Soc Nephrol. 2009 Jan;4(1):57-61.
2Curtis BM, Barrett BJ, Djurdjev O, Singer J, Levin A. Evaluation and treatment of CKD patients before and at their first nephrologist encounter in Canada. Am J Kidney Dis. 2007 Nov;50(5):733-42