Two separate phase II trials found that in treatment naive, non-dialysis patients Hematide could correct anemia when administered monthly at an appropriate dose. Hematide is a novel synthetic, pegylated peptide that binds to and activates the erythropoietin receptor. The product is being developed for treatment of anemia in chronic kidney disease (CKD) and cancer.
Anne-Marie Duliege, vice president of clinical, medical and regulatory affairs for Affymax, said: “As we prepare for phase III clinical trials for Hematide, these data support our goal to evaluate the product in a broad CKD patient population. The phase III studies will assess the safety and efficacy of Hematide in these patient populations and will generate sufficient clinical data to assist physicians in optimizing anemia management in their patients.”
At the time of the presentation, the data generated to date were from two multi-center, open-label studies that have enrolled a total of 304 patients. Hematide was generally well tolerated with an adverse event profile consistent with the chronic kidney disease patient population.