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GSK starts late-stage trials of daprodustat

Drug hopes to treat anaemia caused by chronic kidney disease


GlaxoSmithKline is now enrolling patients into a phase III trial of daprodustat, a drug for anaemia associated with chronic kidney disease (CKD) 

The orally-active hypoxia-inducible prolyl hydroxylase inhibitor (HIF-PHI) could be a $450m product by 2020, according to Credit Suisse forecasts, and is one of a block of new products that GSK hopes will add at least £6bn in sales by that year.

Daprodustat is thought to work by turning on the body's machinery for producing red blood cells that is usually stimulated by reduced oxygen levels in the blood, and could provide an alternative to injectable anaemia treatments such as blood cell stimulator erythropoietin (EPO).

GSK's pivotal trials programme includes two studies involving patients with CKD-related anaemia, who will either be switched from treatment with EPO or who will not have previously been treated for the condition. ASCEND-D will enrol around 3,000 patients on dialysis who have switched from EPO, while ASCEND-ND will involve 4,500 subjects who are not on dialysis and will either be EPO-naïve or switchers. 

The primary outcome measures will be the time to first occurrence of a major adverse cardiovascular event (MACE) and changes in haemoglobin levels over the course of the 12-month studies, with the aim of demonstrating that daprodustat is at least as good as EPO.

Julian Jenkins, who is in charge of the daprodustat development programme at GSK, said: "For many patients with CKD, treating their anaemia comes with risks associated with cardiovascular safety and injectable administration."

GSK is in a race to market with other HIF-PHI developers, including FibroGen, which has a candidate called roxadustat (FG-4592) in late-stage trials in China for anaemia caused by CKD and has licensed overseas rights to AstraZeneca (AZ) and Astellas. Also in phase III is Akebia Pharma's vadadustat, which has been licensed to Mitsubishi Tanabe Pharma in some Asian markets including Japan. 

FibroGen said recently it is on track to file a marketing application for roxadustat in the US in 2018, while Akebia is pitching toward its first regulatory filings the following year. Meanwhile, Bayer has a candidate called molidustat in phase II testing.

Daprodustat was also in phase II testing for peripheral arterial disease (PAD), but no longer seems to be in development for that indication according to GSK's latest pipeline report.

Article by
Phil Taylor

25th November 2016

From: Research



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