Arlene Morris, president and chief executive officer of Affymax, said: “Completion of this comprehensive Hematide program marks a major milestone and we anticipate an intensive period of data compilation and analysis. We look forward to sharing top-line data in the coming months that, if positive, will support our plan to file a NDA for Hematide in chronic renal failure later this year.”
The Hematide phase 3 program consisted of four open-label, randomized active-controlled clinical trials in the US and Europe, including two trials in dialysis patients and two others in patients not on dialysis. The Pearl 1 and Pearl 2 trials conducted in non-dialysis patients were designed to evaluate the safety and efficacy of Hematide compared to darbepoetin alfa, for treating anemia and maintaining hemoglobin levels over time based on the trial protocol.
In dialysis patients, the Emerald 1 and Emerald 2 trials evaluated the safety and efficacy of Hematide in its ability to maintain hemoglobin levels in the target range, when patients were switched from epoetin alfa or epoetin beta to Hematide.
Analysis of efficacy for each of the four studies 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 11-12 g/dl for non-dialysis patients and 10-12 g/dl for those on dialysis.
In all studies, Hematide was dosed once every four weeks while comparator drugs were dosed more frequently according to their product labels. Treatment in each trial was continued until the last patient had been treated for at least 52 weeks. The primary safety assessment will be determined by the analysis of non-inferiority to comparator drugs using a composite cardiovascular endpoint from a safety database pooled from the four phase 3 trials. The duration of the phase 3 program was contingent on collecting a sufficient number of cardiovascular safety events for statistical analysis.