GSK starts phase III studies of daprodustat for anaemia

Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).

The phase III programme includes two studies assessing the safety and efficacy of daprodustat compared to recombinant human erythropoietin.

One study, ASCEND-D, will enrol about 3,000 dialysis dependent subjects with anaemia associated with CKD switching from an erythropoietin-stimulating agent (ESA). 

About 4,500 non-dialysis dependent subjects with anaemia associated with CKD will be enrolled in another study, ASCEND-ND. It will will include patients either switching from or naive to an ESA. 

The co-primary endpoints for both the studies are time taken for the first occurrence of major adverse cardiovascular events (MACE) and mean change in haemoglobin levels between the baseline and efficacy period.

Daprodustat will be evaluated in the two studies whether it is non-inferior or not to recombinant human erythropoietin on the endpoints considered as the primary analysis.

Superiority of the drug will be investigated for the safety endpoint if its non-inferiority of the primary analysis is registered.

The company designed the phase III programme of daprodustat from the data collected in the phase II trials that characterized the relationship of dose and response between the drug and haemoglobin at four weeks besides assessing its safety and tolerability after everyday administration for up to 24 weeks.

GSK vice president and medicine development leader responsible for the daprodustat programme 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.”