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Affymax, Takeda Get Phase II Boost for Hematide

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Takeda Global R&D Center and Affymax achieved 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 (CKD). Preliminary trial data showed that Hematide administered once every four weeks was well tolerated and maintained mean hemoglobin levels between 11 and 12 g/dL in patients with CKD, both pre-dialysis and hemodialysis, over a 12-month period.  
   
The companies also announced the results of two other Hematide studies. One assessed safety and tolerability of the compound in CKD, for patients already on hemodialysis, and the other studied Hematide in CKD patients with Pure Red Cell Aplasia (PRCA), a rare but serious condition in which 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.
   
Dr. David Recker, senior vice president, Clinical Sciences at Takeda said, “The focus for Takeda and Affymax are the needs of patients, which is at the forefront of drug development. Together, we are working to bring this novel potential treatment option to patients with CKD-induced anemia and to the physicians who treat them.”

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