Igraine Plc ARCADIA trial completes and commercialisation plans
09 Septiembre 2021 - 1:00AM
UK Regulatory
TIDMKING
9 September 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, a company founded by renowned biotech entrepreneur and the
company's Executive Chairman, Professor Sir Christopher Evans.
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 Results & Commercialisation Plans
Results from ARCADIA Phase II Clinical Trial of A Potential Therapy for
COVID-19
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. 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 full announcement can be viewed here:www.excaliburhealth.co.uk/news or
www.sgscapital.org
Martin Walton, Executive Director, said: "The data from the trial is very
encouraging and the company looks forward to the next developments in this
exciting project. The trial results are promising and AZD1656 has the potential
to be an important treatment for people with diabetes who have COVID-19."
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)
info@igraineplc.com
Office Line: +44 (0) 20 3778 0755
AQSE Growth Market Corporate Adviser
Peterhouse Capital Limited
Guy Miller / Allie Feuerlein
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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