GSK initiates Phase III programme of daprodustat
UK drug manufacturer GlaxoSmithKline (GSK) has initiated its Phase III programme of daprodustat being developed to treat anaemia associated with chronic kidney disease (CKD).
Daprodustat has been developed as an orally administered hypoxia-inducible factor prolyl hydroxylase inhibitor, which induces production of red blood cells that carry oxygen to where it is needed.
The Phase III programme is characterised by two studies, ASCEND-D, which will enrol approximately 3,000 dialysis dependent patients with anaemia associated with CKD, changing from an erythropoietin-stimulating agent (ESA).
ASCEND-ND is the other study planning to enrol approximately 4,500 non-dialysis dependent subjects with CKD-related anaemia who are either changing to ESA or are naïve to the regimen.
Both studies will be conducted to evaluate the safety and efficacy of daprodustat compared to recombinant human erythropoietin.
The studies will be primarily focused on determining the time taken for the first occurrence of major adverse cardiovascular events (MACE) and baseline change in haemoglobin.
GSK innovation performance and technology vice-president Julian Jenkins said: “For many patients with chronic kidney disease, treating their anaemia comes with risks associated with cardiovascular safety and injectable administration.
“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.”
The phase III programme is based on the data of phase II clinical trials, which were intended to characterise the dose-response relationship between daprodustat and haemoglobin at four weeks and test the safety and tolerability of daprodustat following once-daily administration up to 24 weeks.