Hematide™/peginesatide Overview
Hematide™/peginesatide is an investigational (not yet approved for use) erythropoiesis-stimulating agent (ESA) that is being tested in clinical trials for the treatment of anemia associated with chronic renal failure (CRF). The investigational therapy, co-developed by Affymax (Palo Alto, CA) and Takeda (Osaka, Japan), has been investigated in Phase 3 studies in patients with CRF. In patients with CRF, these trials evaluated the ability of Hematide to correct anemia by raising and maintaining hemoglobin (Hgb) levels within a target of 10-12 g/dL in dialysis patients and 11-12 g/dL in non-dialysis patients. Preliminary top-line results from the Phase 3 clinical program were announced in June 2010 (click here for press release).
In contrast to the current standard of care, recombinant protein-based ESAs, Hematide is a novel, synthetic peptide-based ESA that is immunologically distinct from endogenous human erythropoietin (EPO), a protein produced by the kidneys to stimulate the production of oxygen-transporting red blood cells. The most advanced portion of Hematide's clinical development program is a Phase 3 program that consisted of four studies studies including two in dialysis patients (EMERALD 1 and 2) and two in non-dialysis patients (PEARL 1 and 2) involving approximately 2,600 patients across almost 400 clinical sites in U.S. and Europe. While the development of pure red cell aplasia (PRCA) is listed as a potential adverse reaction to currently approved ESAs, Phase 2 Hematide data have shown that Hematide has the potential to increase and maintain Hgb levels in patients who have developed PRCA as a result of ESA use. PRCA is a rare condition in which the body develops neutralizing antibodies to recombinant ESAs that negate the effects of the ESA as well as the body's naturally produced EPO. PRCA often leaves patients severely anemic and reliant on regularly administered blood transfusions and/or immunosuppressant therapy.
Takeda and Affymax are collaborating on the development of Hematide and plan to co-commercialize the product in the United States. The product, upon approval, will be commercialized in the European Union by Takeda.
While the development of pure red cell aplasia (PRCA) is listed as a potential adverse reaction to currently approved ESAs, Phase 2 Hematide data have shown that Hematide has the potential to increase and maintain Hgb levels in patients who have developed PRCA as a result of ESA use. PRCA is a rare condition in which the body develops neutralizing antibodies to recombinant ESAs that negate the effects of the ESA as well as the body's naturally produced EPO. PRCA often leaves patients severely anemic and reliant on regularly administered blood transfusions and/or immunosuppressant therapy.
Takeda and Affymax are collaborating on the development of Hematide and plan to co-commercialize the product in the United States. The product, upon approval, will be commercialized in the European Union by Takeda.
Peginesatide is the USAN or nonproprietary name for the compound.