Affymax, Inc announced that enrolment has been completed in the remaining phase-3 clinical trial of its lead investigational therapy, Hematide, which is being evaluated for the treatment of anaemia in chronic renal failure patients. Emerald 2 is fully enrolled with over 800 dialysis patients, collectively, from over 90 sites in the United States and Europe.
"With Pearl 1 enrolment completed in July, Pearl 2 in October, Emerald 1 just a week ago and now Emerald 2 fully enrolled, we have now completed enrolment in our pivotal phase-3 programme for Hematide for the treatment of anaemia in chronic renal failure patients," said Arlene Morris, president and chief executive officer at Affymax. "The clock now starts for the 52 week treatment period in Emerald 2, which aligns us for composite data release from all four studies in early 2010, assuming sufficient data collection. 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."
The Hematide phase-3 programme, involving a total of approximately 2,600 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 anaemia and maintaining haemoglobin 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 haemoglobin 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 haemoglobin from baseline. The haemoglobin target range is 11-12 g/dL for studies in non-dialysis patients and 10-12 g/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. Treatment in each study is planned until the last patient has been in the study for approximately 52 weeks. Assessment of safety will include an analysis of non-inferiority to comparator drugs using a composite cardiovascular endpoint from a safety database pooled from all four phase-3 trials. The duration of the phase-3 trials assumes observance of a sufficient number of safety events for statistical analysis.
Hematide is a novel synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an erythropoiesis stimulating agent (ESA).
Affymax is a biopharmaceutical company developing novel drugs to improve the treatment of serious and often life-threatening conditions.