Affymax doses first patient with Hematide

PALO ALTO, Calif.—Affymax Inc. and Takeda Pharmaceutical Co. said October 11 that the Affymax has dosed the first patient with its Hematide in the phase 3 study of the anemia drug in chronic kidney disease patients.

The open-label, randomized controlled program has approximately 2,200 renal failure patients in the United States and Europe, and it includes two trials in patients on dialysis and two trials of patients not on dialysis. The non-dialysis patient trials will compare Hematide to darbepoetin alpha. The dialysis patient trials will compare Hematide in patients already treated with EPO to epoetin alpha or epoetin beta.

The primary efficacy endpoint will be the mean change in hemoglobin from baseline. Affymax said the hemoglobin target will be 11-12 g/dL in non-dialysis CKD patients and 10-12 g/dL in dialysis patients.

In all of the studies, Affymax said patients will be dosed with Hematide once every four weeks for 52 weeks, and the drugs it is being compared with will be dosed based on what their labeling recommends.

“We believe our program is uniquely designed to take advantage of the most current regulatory and medical strategies for the evaluation and use of eythropoiesis-stimulating agents,” said Arlene Morris, president and CEO of Affymax. “Hematide is a novel ESA with the potential to offer monthly dosing to physicians and patients.”

Morris added that the studies will finish enrolling patients in 2008. In addition, Affymax said it expects to submit a New Drug Application to the U.S. Food and Drug Administration for Hematide in CKD in 2010. 

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