LONDON, Sept. 9, 2021 /PRNewswire/ -- St George Street Capital, a UK-based biomedical charity, and Excalibur Medicines Ltd., a biotechnology investment company, are pleased to announce the receipt of the final data from the ARCADIA Phase ll clinical trial which was conducted to assess a therapy that could treat diabetic patients suffering from COVID-19.
In light of the encouraging trial results, St George Street Capital and Excalibur will immediately start to undertake commercial discussions with potential licensees and/or fundraise for further clinical trials to investigate AZD1656 in a larger study. Further analysis to determine the precise nature of the biological effects of AZD1656 that explain the observed clinical outcomes will also be conducted.
The trial data has shown the following:
Efficacy: A strong trend towards reduced mortality in patients receiving AZD1656. This was noted in both mortality on treatment and all-cause mortality, which were lower in the AZD1656 group compared to the placebo group. The strong trend to improved mortality for patients on AZD1656 was observed on top of patients receiving other medication, including dexamethasone, as part of standard of care. Certain clinically and biochemically defined subsets of patients appeared to benefit most from treatment with AZD1656. The data from ARCADIA supports continued investigation of AZD1656 for the treatment of patients with COVID-19, with or without diabetes, in future clinical trials.
Safety and tolerability: AZD1656 was shown to be well-tolerated in this patient population with no serious adverse reactions (SARs) occurring. The degree of glycaemic control, as measured by the need to increase baseline medication requirements or the need to add additional diabetic medications, was no different between the AZD1656 group and the placebo group. The proportion of Serious Adverse Events (SAEs) was numerically lower in the AZD1656 group compared with the placebo group. The proportion of Treatment Emergent Adverse Events (TEAE) was also no different between the groups. Overall no safety concerns were identified regarding the use of AZD1656 in this patient population.
Diabetes, whether type 1 or 2, has been the leading single cause of co-morbidity during the pandemic and one in three of all deaths with COVID-19 in hospital in England have been associated with diabetes.
About the ARCADIA Trial
AZD1656 was identified by St George Street Capital as a potential treatment for people with diabetes infected with COVID-19.
The objectives of the ARCADIA clinical trial were to assess the safety and tolerability of a glucose kinase activator, AZD1656, and to determine the effect of the therapy on clinical improvement and mortality in people with diabetes hospitalised with COVID-19. The trial also explored whether AZD1656 benefits COVID-19 patients via its effects on immune function.
ARCADIA was a randomised, double-blind, placebo-controlled Phase II clinical trial involving 153 patients. ARCADIA was funded by international investment through Excalibur Medicines Ltd, including the Mubadala Sovereign Wealth Fund and an HM Government grant through the UKRI/Innovate UK programme.
Professor John Martin of UCL, Chairman of St George Street Capital and PI on the Innovate UK grant awarded said: "The completion of ARCADIA marks a significant milestone in the history of the charity St George Street Capital. We have demonstrated our ability to rapidly deliver a clinical trial in an area of unmet clinical need, thus fulfilling our mission to accelerate the development of new treatments for people who need them. The promising results from this trial indicate that AZD1656, a simple oral tablet, has the potential to become a new treatment for COVID-19 - independent of viral mutations - initiating a new wave of therapies for clinicians in meeting this global challenge."
Professor Sir Chris Evans, chairman and CEO of Excalibur Healthcare Services, the parent company of Excalibur Medicines Ltd., said: "We are hugely encouraged by this data and are delighted to have played our part arranging this trial. I am particularly grateful to His Royal Highness, the Crown Prince of Abu Dhabi, the Mubadala Sovereign Wealth Fund and our own government in supporting this project. We are looking forward to the next chapter in this exciting journey which could ultimately help people who remain vulnerable to COVID-19."
Notes to editors:
About St George Street Capital
St George Street is a biomedical research charity on a mission to fast-track clinical trials so we can get new treatments as quickly as possible to the people who need them. We apply bold new thinking to unlock the therapeutic potential of therapies and science currently sitting on the shelf in pharma. We are a new type of charity, sourcing investment to accelerate clinical trials, where new science shows great potential and where patients and clinicians are calling out for treatments. St George Street was established in 2017 and brings together a powerful mix of expertise, from investors and business managers to clinic.
About Excalibur Medicines Ltd.
Excalibur Medicines Ltd (EML) is a subsidiary of Excalibur Healthcare Services, founded by leading scientific entrepreneur, Professor Sir Chris Evans, OBE. EML brought together the scientific intellectual property, international funding and a world leading team to take forward the ARCADIA trial. Professor Evans and the Excalibur team sourced investment from Mubadala of Abu Dhabi, one of the world's leading sovereign wealth funds, Excalibur itself and several high net worth individuals. Website: https://excaliburhealth.co.uk/
