Hematide is a peptide-based erythropoiesis stimulating agent (ESA) being developed for the treatment of anemia in patients with chronic kidney disease and cancer. Hematide is currently being evaluated in a phase II clinical trial investigating its safety, pharmacodynamics and pharmacokinetics in patients with chronic kidney disease who are not on dialysis.
The results of the phase I trial showed that Hematide was well tolerated and resulted in sustained dose dependent erythropoietic activity demonstrating increases in circulating reticulocytes in healthy volunteers. At the highest dose tested, Hematide also achieved a clinically and statistically significant increase in hemoglobin from baseline that was sustained for at least a month. Increases in hemoglobin and reticulocytes are indications of red blood cell production.
Affymax scientists reviewed pharmacology studies of Hematide in various animal models. The studies demonstrated that following a single intravenous dose administration of Hematide, the rise in hemoglobin and reticulocytes was dose-dependent and the activity was of extended duration. Tachyphylaxis and Hematide-antibodies were not observed after repeated dosing.
Researchers concluded that Hematide is a potent erythropoiesis stimulating agent that corrects anemia associated with either insufficient erythropoietin production or the formation recombinant erythropoietin (rHuEP) specific antibodies in animals. If, in clinical trials, the results obtained in animals translate into similar effects in humans, Hematide may potentially be of use to correct antibody-mediated anemia, also known as pure red cell aplasia, which can be induced in humans by treatment with rHuEPO products.