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news.Takeda Global R&D Center and Affymax have reported positive 12 month data from their ongoing Phase II trial evaluating the safety and tolerability of Hematide, an investigational drug in development for the treatment of anemia associated with chronic kidney disease.
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Preliminary data from the trial showed that Hematide administered once every four weeks was well tolerated and maintained mean hemoglobin levels between 11 and 12g/dL in patients with chronic kidney disease (CKD), both pre-dialysis and hemodialysis, over a 12 month period.
In addition, the companies have announced the results of two other studies. One study also assessed safety and tolerability of Hematide in CKD, but only for patients already on hemodialysis and a third presentation detailed data relating to the treatment with Hematide of CKD patients with pure red cell aplasia (PRCA), a rare but serious condition, where the body produces antibodies to erythropoiesis stimulating agents (ESAs) and the patient’s endogenous erythropoietin. Patients who develop PRCA are usually transfusion-dependent. In this study, treatment of these patients with Hematide resulted in maintenance of hemoglobin levels within target in the absence of transfusions.
Andrzej Wiecek, trial investigator, said: “We are pleased that these trials show the potential for Hematide to be dosed on a once-monthly basis while maintaining stable hemoglobin levels.”