GlaxoSmithKline starts Phase III studies of daprodustat for anaemia

GlaxoSmithKline has started a phase III development programme to investigate daprodustat for anaemia associated with chronic kidney disease.

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

ASCEND-D will enrol around 3,000 dialysis dependent subjects with anaemia associated with chronic kidney disease switching from an erythropoietin-stimulating agent (ESA).

Meanwhile, ASCEND-ND will enrol approximately 4,500 non-dialysis dependent subjects with anaemia associated with CKD, and will include patients either switching from or naive to an ESA.

For both studies, the co-primary endpoints are time to first occurrence of major adverse cardiovascular events and mean change in haemoglobin between the baseline and efficacy period.

Julian Jenkins, vice president and medicine development leader responsible for the daprodustat programme, 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."

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