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A new therapy that could treat people with diabetes suffering from COVID-19 is to undergo an advanced clinical trial in the UK.  The first patient will be dosed this week.

The Medicines and Healthcare products Agency (MHRA) has approved the trial following new preclinical research that suggests a glucose kinase activator (AZD1656) could help diabetes sufferers infected with coronavirus by dampening the overactive response of the immune system typically acute in those patients with raised blood glucose levels. The trial will involve hospitalised patients with mild to moderate COVID-19 symptoms and if successful the compound could ultimately be prescribed by a GP for people with diabetes presenting with early COVID symptoms.

People living with diabetes face a significantly higher risk of dying with COVID-19. One in three of all deaths with COVID-19 in hospital in England have been associated with diabetes. Diabetes, whether type 1 or 2, has been the leading single cause of co-morbidity during this pandemic. People living with type 1 diabetes are at three and a half times the risk, and people living with type 2 diabetes are at double the risk of dying in hospital with the virus compared to people without diabetes¹.

This exciting new development, believed to be unique among the hundreds of COVID-related research projects around the world today, was arranged and structured by Professor Sir Chris Evans, Chairman and CEO of Excalibur Healthcare Services, through a new vehicle,  Excalibur Medicines Ltd, which brought together the scientific intellectual property, international funding and a world leading team to drive the project forward.  The idea of investigating AZD1656 in this setting was conceived by Professor John Martin and his team at St George Street, a UK-based biomedical research charity. The drug was originally developed for another indication by Astra Zeneca, who have agreed to provide the drug substance for the trial, while St George Street will lead the clinical trial.

The trial, named ARCADIA, will commence with Professor Evans and the Excalibur team having sourced investment from Mubadala of Abu Dhabi, one of the world’s leading sovereign wealth funds, Excalibur itself and several high net worth individuals. This is in addition to funding secured from the UK Government through the UKRI / Innovate UK programme. This enables the trial to go ahead at speed in 150 patients over a 4 month timeframe at multiple sites in the UK.

Professor Evans said: “All of us supporting this trial recognise this drug has the potential to make a huge difference to people with diabetes who are unfortunate enough to contract coronavirus and we foresee a significant impact on the level of fatalities in the future. Treatments such as this could be vital as we are likely to be living with this horrific virus for some time to come.”

David Tapolczay, CEO St George Street, said: “Given the current crisis, we have paused all our current research programmes to focus totally on this clinical trial and evaluate this potentially life-saving new drug. Our charity was set up to accelerate the delivery of treatments to patients and this ethos is needed now more than ever before. We want to do everything in our power to ensure patients recover from this terrible virus.”

Professor John Martin, Chairman of the charity and Principal Investigator on the grant awarded by UKRI, said: “Novel research thinking in an interdisciplinary group combined with the drive of the charity and the excellent relationship we have with Astra Zeneca have produced the potential for a great therapeutic leap.  This also has potential for non-diabetic patients with COVD-19.”