Further to the update released by Vela on 9 September 2021, the Board of Vela (AIM: VELA) has been informed by St George Street Capital (“SGSC”) that the Clinical Study Report (“CSR”) from the ARCADIA Phase II clinical trial has been completed. SGSC are undertaking commercial discussions with potential licensees and partners and examining options for the next stage of the development and approval process. The finalisation of the CSR formally marks the end of the ARCADIA trial.
Details of Vela’s economic interest in the potential commercialisation of the Asset, the Asset and the ARCADIA trial were included in the announcement published by Vela on 20 October 2020.
James Normand, Director of Vela, commented: “The board of Vela is delighted to be informed of this significant development in what is the Company’s most material investment. We note that SGSC is now moving forward with the proposed commercialisation of the AZ1656 drug and we look forward to positive news on this process in the near future.”
Full details of the joint press release issued today by SGSC and Excalibur Medicines Ltd, a biotechnology investment company, is extracted below. The Asset is referred to in the press release below as AZD1656:
St George Street Capital, a UK-based biomedical charity, and Excalibur Medicines Ltd., a biotechnology investment company, are pleased to announce the completion of the Clinical Study Report from the ARCADIA Phase ll clinical trial which was conducted to assess a therapy that could treat diabetic patients suffering from COVID-19.
St George Street Capital and Excalibur are now undertaking commercial discussions with potential licensees and partners, and examining options for the next stage of the development and approval process. Further analysis to determine the precise nature of the biological effects of AZD1656 that explain the observed clinical outcomes will also be conducted.
The finalisation of the CSR formally marks the end of the ARCADIA trial. The trial data has shown the following:
Efficacy : A strong trend towards reduced mortality in patients receiving AZD1656. 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.
Safety and tolerability : AZD1656 was shown to be well-tolerated in this patient population with no serious adverse reactions (SARs) occurring. 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.
Professor John Martin of UCL, Chairman of St George Street Capital and PI on the Innovate UK grant awarded said: “The completion of the Clinical Study Report is a major milestone and we are encouraged by the trial findings which 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 delighted to have played our part arranging this trial and this report confirms the great potential of AZD1656 to help people who remain vulnerable to COVID-19.”
Notes to editors:
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.
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