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UPDATE: Glaxo "particularly pleased" with daprodustat Phase 3 results

16th Jul 2021 12:39

(Alliance News) - GlaxoSmithKline PLC on Friday said its five Phase 3 studies of daprodustat have returned positive results for patients with anaemia due to chronic kidney disease.

GSK noted the headline results come from its Phase 3 ASCEND programme, which is looking into the efficacy and safety profile of daprodustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for patients with anaemia due to chronic kidney disease.

"The ASCEND programme showed that daprodustat met its primary efficacy endpoint in each study, demonstrating an improvement in haemoglobin levels in untreated patients and maintaining Hgb levels in patients treated with an erythropoietin stimulating agent, a standard treatment option, in patients with anaemia of CKD," the pharma giant explained.

Hal Barron, chief scientific officer and president of Research & Development at GSK, added: "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 3 ASCEND programme and look forward to working closely with regulators as we plan for our submissions."

Daprodustat is currently approved in Japan as Duvroq for patients with renal anaemia. It is not approved anywhere else in the world.

Earlier Friday, GSK set out plans to transform a site in Stevenage, with the pharmaceutical company in the hunt for a development partner to turn the English town into a life sciences leader.

GSK said it seeks to unlock GBP400 million in new investment from the private sector, and aims to create 5,000 "highly-skilled" jobs over the next five to 10 years.

"GSK has today announced that it has formally started the process of seeking a development partner to transform land within the company's existing 92-acre research & development site in Stevenage into one of Europe's largest 'cluster' for biotechnology and other early-stage life science companies," the company explained.

It is a vision GSK has developed alongside the UK government and the local council in Stevenage, which is in Hertfordshire, just north of London. GSK itself is based in Brentford, Middlesex, in the west of London.

GSK plans to select a development partner later this year, with a view of beginning work on the campus in 2022.

GSK Senior Vice President for Medicinal Science & Technology Tony Wood said: "The past 18 months has shown the UK life sciences sector at its best and the UK has recently unveiled an ambitious 10-year vision for the UK life sciences sector. Our goal is for Stevenage to emerge as a top destination for medical and scientific research by the end of the decade. We are excited to find a development partner to realise our vision to foster the next generation of world-class scientists and biotechnology firms in Britain.

"If successful, the new campus could attract several world-class research organisations to Stevenage, creating exciting opportunities for collaboration in a state of the art, life science ecosystem."

GSK shares were 0.5% higher at 1,414.20 pence each in London on Friday midday.

By Eric Cunha; [email protected] and Paul McGowan; [email protected]

Copyright 2021 Alliance News Limited. All Rights Reserved.


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