Shire launches Ph IIIb Dynepo trial

UK drugmaker Shire has initiated a new Phase IIIb clinical trial to evaluate two new dosing schedules of Dynepo (epoetin delta), the first commercial erythropoiesis-stimulating agent produced in a human cell line. The agent is used in the treatment of anemia in patients with chronic kidney disease.

Patients with anemia have reduced hemoglobin levels and the firm noted that Dynepo has previously been shown to be as effective as epoetin alfa in increasing and then maintaining hemoglobin levels in the target range (10-12g/dL) in patients with anemia 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.

This open-label, randomized 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.