GlaxoSmithKline (GSK) has revealed positive data for its investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) daprodustat in patients with anaemia due to chronic kidney disease (CKD).
GSK’s ASCEND programme – comprised of five Phase III studies – enrolled over 8,000 patients with anaemia due to CKD across the CKD disease course.
According to GSK, daprodustat was well tolerated in both non-dialysis and dialysis populations, with data on the oral HIF-PHI from two pivotal studies shared at the recent American Society of Nephrology’s meeting.
The ASCEND-ND trial – focused on non-dialysis patients – and the ASCEND-D trial – focused on dialysis patients – each met their primary efficacy and safety endpoints.
The efficacy results from both studies showed that daprodustat improved or maintained patients within their target haemoglobin (Hb) range.
Results from the prespecified primary safety analysis of the intention-to-treat (ITT) population also demonstrated similar rates of major adverse cardiovascular events (MACE), defined as all-cause mortality, non-fatal myocardial infarction or non-fatal stroke independently within each trial.
In a statement, GSK said daprodustat is the first oral HIF-PHI to clearly demonstrate positive efficacy coupled with no increased cardiovascular risk in this patient population.
“Over 700 million people suffer from chronic kidney disease worldwide, and an estimated one-in-seven of these patients suffers from anaemia,” said Hal Barron, chief scientific officer and president, R&D, GSK.
“Grounded in research-based on Nobel Prize-winning science, we believe these data show daprodustat has the potential to transform the treatment landscape for these patients, many of whom have limited treatment options today,” he added.