Igraine Plc - ARCADIA Update and Commercialisation Plans PR Newswire

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