Igraine Plc ARCADIA Update and Commercialisation Plans

 
TIDMKING 
 
14 December 2021 
 
THE INFORMATION CONTAINED WITHIN THIS ANNOUNCEMENT IS DEEMED BY THE COMPANY TO 
CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER THE MARKET ABUSE REGULATION 
(EU) NO. 596/2014, AS AMENDED ("MAR"). ON THE PUBLICATION OF THIS ANNOUNCEMENT 
VIA A REGULATORY INFORMATION SERVICE ("RIS"), THIS INSIDE INFORMATION IS NOW 
CONSIDERED TO BE IN THE PUBLIC DOMAIN. 
 
                                  Igraine plc 
 
                                  AQSE: KING 
 
                         ("Igraine" or "the Company") 
 
  Investee Update: Excalibur Medicines reports completion of ARCADIA trial & 
                  starts to progress commercialisation plans 
 
Investee: EML 
 
Igraine plc maintains a 2% Equity Interest in, Excalibur Medicines Ltd ("EML"), 
consistent with the terms of the co-investment agreement entered with Excalibur 
Healthcare Services. 
 
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, several high net 
worth individuals, Igraine plc (AQSE: KING) & an HM Government grant through 
the UKRI/Innovate UK programme. 
 
Excalibur Medicines Ltd ("EML") has secured exclusive rights to and owns the 
patents on a drug, AZD1656, which is being developed as a potential therapeutic 
for people with diabetes suffering from COVID-19. As there are very few new 
therapeutics in development for COVID-19 and associated virally transmitted 
diseases (most research is in combining existing treatments) this has the 
potential to be highly attractive to big pharma and biotech buyers. 
 
                         ARCADIA CLINICAL STUDY REPORT 
 
St George Street Capital, a UK-based biomedical charity, and Excalibur 
Medicines Ltd., a biotechnology investment company, are pleased to announce 
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 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, Executive Chairman of Igraine, and 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." 
 
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. The clinical trial was arranged and structured by 
Professor Sir Chris Evans, Chairman and CEO of Excalibur Healthcare Services, 
through its subsidiary, Excalibur Medicines Ltd. Sir Chris worked closely with 
Professor John Martin and his team at St George Street, a UK-based biomedical 
research charity, which secured the initial project and permission to run the 
trial from AstraZeneca. 
 
The Directors of the Company, who have issued this RIS announcement after due 
and careful enquiry, accept responsibility for its content. 
 
Enquiries 
 
Company: 
 
Martin Walton (Executive Director) 
 
Steve Winfield (Executive Director) 
 
AQSE Growth Market Corporate Adviser 
 
Peterhouse Capital Limited 
 
Guy Miller / Mark Anwyl 
 
Tel: +44 (0) 207 469 0930 
 
Media inquiries: 
 
Ramsay Smith, Media House International 
 
ramsay@mediahouse.co.uk: +44 (0) 7788414856 
 
 
 
END
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