GlaxoSmithKline has begun Phase III development of daprodustat, testing its potential as a treatment for anaemia associated with chronic kidney disease (CKD).
Anaemia commonly arises in patients with kidney dysfunction because the kidneys no longer produce enough of the hormone erythropoietin, which stimulates red blood cell production. Patients with chronic kidney disease or kidney failure can experience varying degrees of anaemia as their disease progresses, limiting oxygen delivery to tissues and thus contributing to symptoms such as weakness and fatigue.
Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, which promotes the production of red blood cells that carry oxygen to where it is needed.
The Phase III programme for the drug includes two studies evaluating its safety and efficacy compared to recombinant human erythropoietin in dialysis dependent subjects with anaemia associated with CKD (ASCEND-D) and in non-dialysis dependent patients with the condition (ASCEND-ND).
The co-primary endpoints for both trials are time to first occurrence of major adverse cardiovascular events (MACE) and mean change in haemoglobin between the baseline and efficacy period (mean over Weeks 28-52).
"For many patients with chronic kidney disease, treating their anaemia comes with risks associated with cardiovascular safety and injectable administration," noted Julian Jenkins, vice president and medicine development leader. "The start of Phase III studies of daprodustat is an important step in our work to explore whether daprodustat could address those risks and provide a potential alternative, oral treatment option."