GlaxoSmithKline (GSK) has reported positive headline data gathered from five clinical trials of the Phase III ASCEND programme of daprodustat to treat anaemia in chronic kidney disease (CKD) patients.
Daprodustat is an experimental, oral inhibitor of hypoxia-inducible factor prolyl hydroxylase. It is meant to treat anaemia caused by CKD in adults on and not on dialysis.
According to data from the Phase III programme, the drug met the primary efficacy endpoint of all the five trials, showing an improvement in haemoglobin (Hgb) levels in untreated participants.
The drug also maintained Hgb levels in people who received treatment with an erythropoietin stimulating agent (ESA), a standard option, in those with anaemia of CKD.
ASCEND-ND and ASCEND-D, the main cardiovascular outcomes studies for non-dialysis and dialysis patients, respectively, found daprodustat to be non-inferior to an ESA on their co-primary endpoint – the risk of major adverse cardiovascular events.
GSK chief scientific officer and R&D president Dr Hal Barron said: “I am particularly pleased with the results from the ASCEND-ND and ASCEND-D studies given the importance of managing cardiovascular outcomes for patients who are currently suffering from anaemia due to chronic kidney disease, as well as the need to provide a convenient, oral treatment option.
“We will continue to analyse the data from the robust Phase III ASCEND programme and look forward to working closely with regulators as we plan for our submissions.”
Apart from ASCEND-D and ASCEND-ND, the Phase III programme comprised the ASCEND-ID study for subjects just beginning dialysis, ASCEND-NHQ for quality of life assessments and ASCEND-TD for dosing regimens of thrice weekly.
Daprodustat was generally well tolerated in non-dialysis and dialysis patients across the programme. The treatment-emergent adverse events occurrence was comparable between treatment arms.
The programme recruited a total of more than 8,000 participants who received treatment for up to 3.75 years. The complete data from these five trials is expected to inform global regulatory submissions.
Earlier this month, GSK and its partner Sanofi secured the approval to conduct a Phase III trial of their adjuvanted recombinant-protein Covid-19 vaccine candidate in India.