First results from a phase II clinical study with CERA (Continuous Erythropoiesis Receptor Activator) in dialysis patients with chronic renal anaemia have shown that Roche's innovative new chemical entity delivers potent and sustained stimulation of red blood cell formation at dosing intervals of up to once every three weeks. CERA effectively increased haemoglobin at all studied doses, with increasing doses providing a more rapid response and extended dosing intervals not influencing the magnitude of the response. The results were presented during the annual meeting of the American Society of Nephrology (ASN) 14-17 November in San Diego, USA.
Phase III studies in renal patients are poised to begin in Europe and the USA early next year.
CERA is a Continuous Erythropoiesis Receptor Activator. Studies have shown that CERA has unique activity at the receptor site. It is postulated this is related to its repeated and rapid attachment and dissociation from the receptor involved in triggering erythropoiesis (red blood cell formation) together with an extended serum half-life. This results in more potent stimulation of erythropoiesis, both in magnitude and duration, compared to standard epoetins.
"This first release of new data supports our belief that CERA will provide physicians and patients with better management options in anaemia," according to William M. Burns, head of Roche's pharmaceuticals division. "This is an important step forward in achieving our goal of worldwide commercialization of CERA, allowing us access to the US market and further strengthening Roche's position in anaemia management."
Commenting on the study results professor Angel LM de Francisco from Hospital Universitario Valdecilla, Santander in Spain said, "This study demonstrates that CERA has potent erythropoietic activity in patients with chronic renal anaemia on dialysis. Higher doses resulted in faster response times and higher response rates. These results are encouraging for patients in the future as they may benefit from less frequent dosing intervals. For nephrologists this may also mean that they don't need to adjust the dose as frequently to achieve the desired target."