Takeda Global Research & Development Center, Inc. and Affymax, Inc. reported positive 12 month data from their ongoing phase 2 trial evaluating the safety and tolerability of Hematide, an investigational drug in development for the treatment of anaemia associated with chronic kidney disease (CKD).
Preliminary data from the trial showed that Hematide administered once every four weeks was well tolerated and maintained mean haemoglobin levels between 11 and 12 g/dL in patients with CKD, both pre-dialysis and hemodialysis, over a 12 month period. The results were presented by Andrzej Wiecek, MD, trial investigator and head of Nephrology, Medical University of Silesia, Katowice, Poland, at the 45th ERA-EDTA Congress taking place in Stockholm, Sweden.
In addition, the companies announced the results of two other studies. One study also assessed safety and tolerability of Hematide in CKD, but only for patients already on hemodialysis and a third presentation detailed data relating to the treatment with Hematide of CKD patients with Pure Red Cell Aplasia (PRCA), a rare but serious condition, where the body produces antibodies to erythropoiesis stimulating agents (ESAs) and the patient's endogenous erythropoietin. Patients who develop PRCA are usually transfusion-dependent. In this study, treatment of these patients with Hematide resulted in maintenance of haemoglobin levels within target in the absence of transfusions.
Commenting on these results, Dr Wiecek said, "Maintaining average haemoglobin levels within the desired target range with infrequent injections is an important step forward in the treatment of patients with anaemia caused by chronic kidney disease. We are pleased that these trials show the potential for Hematide to be dosed on a once-monthly basis while maintaining stable haemoglobin levels".
Anaemia is a common complication for patients with CKD, which affects approximately 40 million people in Europe - nearly eight per cent of the population. Treatment of anaemia in patients with CKD is usually considered when haemoglobin levels fall to 11 g/dL or below.
Speaking about the partnership which led to the latest developments for Hematide, Dr David Recker, senior vice president, Clinical Sciences at Takeda said, "The focus for Takeda and Affymax are the needs of patients, which is at the forefront of drug development. Together, we are working to bring this novel potential treatment option to patients with CKD-induced anaemia and to the physicians who treat them".
Hematide, a novel, synthetic, peptide-based erythropoiesis-stimulating agent (ESA), is a product candidate that has demonstrated the ability to stimulate the production of red blood cells. If proven safe and effective in clinical trials, it may offer physicians and patients an alternative therapy to recombinant erythropoietin, a hormone that stimulates red blood cell formation.
Affymax and Takeda are collaborating on the development of Hematide. The product will be commercialized in the European Union by Takeda. Affymax is conducting phase III clinical trials for Hematide to treat anaemia in chronic renal failure indications. Takeda is also focusing on a recently initiated phase I clinical trial to evaluate Hematide to treat chemotherapy-induced anaemia in prostate, breast and non-small cell lung cancer patients.