The Phase III evaluation of Hematide for anemia correction in chronic renal failure (Pearl 2) is fully enrolled with over 490 non-dialysis patients from over 60 sites in the US and Europe.
The Hematide Phase III program, involving a total of approximately 2,400 chronic renal failure patients, consists of four open-label, randomized controlled clinical trials in the US and Europe, including two trials in patients on dialysis and two trials in patients not on dialysis. The trials in non-dialysis patients, called Pearl 1 and Pearl 2, are evaluating the safety and efficacy of Hematide compared to darbepoetin alfa in correcting anemia and maintaining hemoglobin levels over time.
In dialysis patients, the trials, called Emerald 1 and Emerald 2, are evaluating the safety and efficacy of Hematide and its ability to maintain hemoglobin levels in a corrected range when patients are switched from epoetin alfa or epoetin beta to Hematide.
Analysis of efficacy for each study is based on assessments of non-inferiority to the comparator drugs. The primary efficacy endpoint is the mean change in hemoglobin from baseline. The hemoglobin target range is 11-12g/dl for studies in non-dialysis patients and 10-12g/dl for studies in dialysis patients. In all studies, Hematide is dosed once every four weeks while comparator drugs are dosed in accordance with their respective product labels.
Anne-Marie Duliege, chief medical officer of Affymax, said: “We are now focusing our attention on finalizing enrollment in our two dialysis trials, Emerald 1 and 2, which we expect to be completed by year end. Our goal is to generate results, with data from all four studies, in early 2010. Consistent with our previous guidance, we expect to submit a new drug application for Hematide in chronic renal failure in 2010 if all goes as planned.”