Vela Technologies Regulatory News (VELA)

7 March 2022

Vela Technologies plc

("Vela" or "the Company")

Update re. St George Street Capital Limited COVID-19 trial

The Board of Vela (AIM: VELA), an AIM-quoted investing company focused on early-stage and pre-IPO disruptive technology investments, notes the announcement made by St George Street Capital ("SGSC") which provides an update on the positive outcome of the ARCADIA COVID-19 therapy trial.

Under an agreement entered into in August 2019, SGSC acquired the right to develop and commercialise two assets from a major global pharmaceutical company, one of which includes the licence to a drug that could be beneficial to diabetic patients suffering with COVID-19 (the "Asset"). 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:

"This update from SGSC indicates that the promise shown by earlier test results (which we have reported on previously) is being maintained. We are pleased that the latest analysis of the results of the study of the application of the AZD1656 treatment is sufficiently encouraging to result in active engagement with potential commercial partners; and thus to vindicate our decision to invest. We remain confident that the AZD1656 treatment has the potential to show a healthy return for SGSC and therefore for Vela."

Full details of the joint press release issued today by SGSC and Excalibur Medicines Ltd ("EML"), a biotechnology investment company, is extracted below. The Asset is referred to in the press release below as AZD1656:

Further analysis of data from the ARCADIA clinical study confirms that the addition of AZD1656 treatment to standard care resulted in fewer deaths and earlier hospital discharge in COVID-19 patients than did placebo treatment.

The ARCADIA Phase II multi-centre study was undertaken in over 150 diabetic patients hospitalised due to moderate to severe COVID-19 infection. Patients received either AZD1656 or placebo daily for up to 21 days in addition to standard care and antidiabetic medications. To be clear, all patients in the trial received standard of care treatment (over 70% in both groups received dexamethasone) with those in the drug group receiving AZD1656 in addition. No deaths occurred in those receiving AZD1656 in the first week of treatment, whereas six deaths occurred in the placebo group. All-cause mortality rates within 28 days of admission favoured the AZD1656 patients, with only four deaths occurring, versus nine deaths in the placebo group.

Thirty patients in the AZD1656 group (38%) were discharged from hospital within seven days of admission, but only 18 patients (25%) receiving placebo treatment. AZD1656 treatment was shown to be safe and well-tolerated.

In addition to the clinical benefit observed in this high-risk patient group, the immunological data gathered from the trial strongly supports SGSC's rationale for the ARCADIA study by confirming that AZD1656 is an immunomodulator which damps down the inflammatory response characteristic of COVID-19 infection, while enhancing the virus-specific immune response.

Thus far, only a small number of repurposed or repositioned drugs have demonstrated benefits in treating COVID-19 infection in early clinical study1. SGSC believes that AZD1656 has the potential to become a valuable addition to the very small number of available COVID-19 drug treatments, offering a safer and more effective alternative to immunomodulatory treatments such as dexamethasone and other steroids, infused anti-cytokines (such as tocilizumab) and Janus kinase inhibitors2.

AZD1656 has an important advantage over small molecule and antibody antiviral agents in that due to its immodulatory effect, efficacy is unlikely to be compromised in treating disease caused by new coronavirus variants. The highly infectious Omicron variant appears to be associated with milder disease symptoms and lower hospitalisation rates, but we may not be so fortunate with future variants. "Variant agnostic", readily stockpiled, transported and easily administered treatments such as AZD1656 are essential for future pandemic preparedness.

SGSC is actively engaged in commercial discussions with appropriate global and regional pharmaceutical companies, with the objective of outright sale, partnership in future development or securing funding for the additional clinical studies necessary to get this to market. Ideally AZD1656 would be evaluated in broader non-diabetic patient populations, both hospitalised patients and those at higher risk of hospitalisation due to underlying health conditions. Despite the unknowns around the evolution of the pandemic, SGSC believes that AZD1656 has the potential to generate significant long-term revenue.

The COVID-19 pandemic has been truly global, and SGSC believes that AZD1656 could be particularly valuable in countries where limited hospital resources, low vaccine uptake and a high prevalence of vulnerable individuals have conspired to push up hospitalisation and death rates.

About AZD1656

AZD1656 was originally developed by AstraZeneca as a diabetes treatment and has an extensive record of safety in clinical studies involving more than one thousand subjects. Preclinical data suggested a likely immune mode of action, leading SGSC to secure a licence to the agent as a therapy for inflammatory conditions.

In addition to the ARCADIA study supported by EML, the Mubadala Sovereign Wealth Fund, Chlodwig Enterprises and UKRI / Innovate UK, SGSC has actively built on the scope of AZD1656 through patent filing (COVID-19 combination treatment) and intends to exploit the beneficial immunomodulatory effect in immune dysfunction applications.

[1] COVID-19 early treatment: real-time analysis of 1,489 studies. https://c19early.com. Accessed 3rd Match 2022

[2] NIH Covid-19 Treatment Guidelines. Table 4f. Characteristics of Immunomodulators. https://tinyurl.com/3jbeucyh Accessed 3rd March 2022

For further information, please contact:

About Vela Technologies 

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.