UK drugmaker Shire has initiated a new Phase IIIb clinical trial to evaluate two new dosing schedules for Dynepo its erythropoiesis-stimulating agent intended for the treatment of anaemia in patients with chronic kidney disease.
Patients with anaemia have reduced haemoglobin levels and the firm noted that Dynepo has previously been shown to be as effective as epoetin alfa in increasing and then maintaining haemoglobin levels in the target range (10-12g/dL) in patients with anaemia associated with CKD when initially given three times per week by the intravenous route. Shire added that it is also effective when given twice per week via the subcutaneous route.
The new open-label study will investigate the efficacy and safety profiles of different starting doses of the agent administered by subcutaneous injection, which are at a lower frequency (once-weekly and once every two weeks) than those currently approved for subcutaneous administration.
Dynepo is the first erythropoiesis-stimulating agent (ESA) to be produced by in a human cell line, via activation of the gene which codes for erythropoietin in human cells, rather than cloning and transferring these genes into animal cells, the method by which rival drug Epogen (epoetin alfa) from Amgen is produced.
Despite this difference, Shire is effectively blocked from launching the product in the USA after an appeals court in August ruled that it infringed two Amgen patents, but could be in a position to introduce it in Europe next year.
Dr Iain Macdougall, who will serve as lead investigator of the new study and is consultant nephrologist in the renal unit of King’s College Hospital, London commented: “If the study demonstrates the efficacy of the different dosing schedules of Dynepo, it will allow future flexibility in the frequency of subcutaneous administration of the product.”
An interesting secondary endpoint of this study is to also monitor diabetic retinopathy, the progressive damage to the eye’s retina, in those patients with anaemia, diabetes and CKD, he added.