Affymax, Inc. announced that it plans to initiate phase 3 clinical studies with Hematide in chronic renal failure patients following recent discussions with the United States Food and Drug Administration (FDA) on the design of the phase 3 clinical trial programme. Hematide is the company's lead drug in development for the treatment of anaemia.
"Following meetings with the FDA, we believe we are well positioned to take advantage of the most current thinking on the evaluation and use of erythropoiesis stimulating agents," said Arlene M. Morris, president and chief executive officer of Affymax. "We look forward to beginning our Phase 3 program, with enrolment expected to commence later this year. Once we begin to enter patients into the program, we expect it will take approximately 12 months to complete enrolment for the planned Phase 3 studies."
The phase 3 programme will include four open-label, randomized controlled clinical trials involving a total of approximately 2,200 chronic renal failure patients, including those on dialysis and not on dialysis. Two trials in non-dialysis patients are designed to evaluate the safety and efficacy of Hematide compared to darbepoetin alfa in correcting anaemia and maintaining haemoglobin in a corrected range over time. In dialysis patients previously-treated with EPO, two trials will evaluate the safety and efficacy of Hematide and its ability to maintain haemoglobin levels in a corrected range compared to epoetin alpha or epoetin beta when patients are switched from either of these epoetins to Hematide. Analysis of efficacy and safety for all studies will be based on assessments of non-inferiority to the comparator drugs. The primary efficacy endpoint will be the mean change in haemoglobin from baseline. The haemoglobin target range will be 11-12 g/dL for studies in non-dialysis patients and 10-12 g/dL for studies in dialysis patients. In all studies, Hematide will be dosed once every four weeks while comparator drugs will be dosed in accordance with their respective product labels. Treatment in each study will be continued until the last patient has been treated for 52 weeks. Assessment of safety will include a composite cardiovascular endpoint from a pooled safety database. The company expects to submit a New Drug Application for Hematide in chronic renal failure in 2010 if all goes as planned.
Hematide is a novel synthetic, pegylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an erythropoiesis stimulating agent. The product is being developed for treatment of anaemia in patients with chronic renal failure and cancer patients receiving chemotherapy.