Affymax Inc. has announced results to date from two separate phase II clinical trials of Hematide in dialysis and non-dialysis chronic kidney disease (CKD) patients.
The data showed that in treatment naive, non-dialysis patients Hematide could correct anaemia when administered monthly at an appropriate dose. Similarly, the data in dialysis patients previously treated with three-times weekly Epoetin Alfa demonstrated that mean haemoglobin (Hgb) levels could be maintained at clinically acceptable levels following a switch to once monthly dosing of Hematide at an appropriate dose. Iain C. Macdougall presented the data, at the World Congress of Nephrology meeting being held in Rio de Janeiro.
"These data show that Hematide results in appropriate management of haemoglobin levels in a broad spectrum of patients with CKD from early-stage patients not on dialysis to patients with end-stage renal disease requiring continuous dialysis support," said Dr Macdougall. "Anaemia is a pervasive problem in the chronic kidney disease patient population. Being able to manage and control anaemia allows treating physicians to focus attention on management of the patient's underlying renal disease."
At the time of the presentation, the data generated to date were from two multi-centre, open-label studies that have enrolled a total of 304 patients. Safety data were based on the entire patient population, while pharmacodynamic data were based on 180 patients who had mostly completed six months of treatment at European and US sites.
Of those, 90 treatment naive CKD patients who were not on dialysis in the correction study were treated with Hematide once every four weeks. The mean Hgb level was 10.2 g/dL at study entry and was increased to greater than 11 g/dL following an initial dose of Hematide. In the maintenance-conversion study, 90 patients previously treated with Epoetin Alfa were switched to Hematide once every four weeks. The mean baseline Hgb level, which was 11.5 g/dL at baseline, was maintained within +/- 1 g/dL at the end of six months of treatment. Hematide was generally well tolerated with an adverse event profile consistent with the chronic kidney disease patient population.
Anne-Marie Duliege, vice president, Clinical, Medical and Regulatory Affairs for Affymax added, "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 optimising anaemia management in their patients."