Further to the update released by Vela on 6 September 2021, the Board of Vela has been informed by St George Street Capital (“SGSC”) that, following receipt of the final data from the ARCADIA Phase II clinical trial, SGSC will immediately start to undertake commercial discussions with potential licensees and/or fundraise for further clinical trials to investigate SGS002 (“the Asset”) in a larger study.
Further analysis to determine the precise nature of the biological effects of the Asset that explain the observed clinical outcomes will also be conducted.
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.
Full details of the press release issued today by SGSC and Excalibur Medicines Ltd is extracted below. The Asset is referred to in the press release below as AZD1656:
St George Street Capital, the UK-based biomedical charity, is pleased to announce the receipt of the final data from the ARCADIA Phase II clinical trial which was conducted to assess a therapy to treat diabetic patients suffering from COVID-19.
In light of the encouraging trial results, St George Street Capital 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.
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 and an HM Government grant through the UKRI/Innovate UK programme.
Professor John Martin of UCL, Chairman of SGSC 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.”
SGSC lock-in agreement
SGSC holds 1,100,000,000 ordinary shares in Vela, representing 7.13 per cent. of Vela’s issued share capital. SGSC’s ordinary shares are subject to a lock-in agreement until the successful completion of Phase II of the ARCADIA trial, or for a period of two months following completion of the ARCADIA trial, should the outcome of the trials not meet the minimum threshold. Following the minimum threshold of primary/secondary and safety endpoint conditions being met, of the ARCADIA Phase II clinical trial, the lock-in period for SGSC’s shareholding will end on 10 September 2021.
For further information, please contact:
Brent Fitzpatrick, Non-Executive Chairman
James Normand, Executive Director
Tel: +44 (0) 7421 728875
About Vela Technologies plc
Vela Technologies plc (AIM: VELA) is an investing company focused on early stage and pre-IPO long term disruptive technology investments. Vela’s investee companies have either developed ways of utilising technology or are developing technology with a view to disrupting the businesses or sector in which they operate. Vela Technologies will also invest in already-listed companies where valuations offer additional opportunities.
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