The Board of Vela notes the recent update published by St George Street Capital Limited (“SGS”) and is pleased with the progress made and the approval received in Czech Republic and Romania in relation to its ARCADIA clinical trial to test SGS002 (“the Asset”), a drug that could be beneficial to diabetic patients suffering from COVID-19.
The full announcement can be found in the News segment of the SGS website, https://www.sgscapital.org/ , and is copied below.
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.
SGS holds 1,100,000,000 ordinary shares in Vela, representing 9.11 per cent. of Vela’s issued share capital. These 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.
The update issued by SGS is reproduced in full below:
Covid-19 Trial Update – 04-01-21
Approval Received to Begin Recruiting in Czech Republic and Romania
The ARCADIA clinical trial is a randomised, placebo-controlled clinical trial to assess the safety and efficacy of AZD1656 in patients with either Type 1 or Type 2 diabetes and admitted to hospital with COVID-19. The trial, which is sponsored by the UK charity St George Street, has successfully recruited 50 of the planned 150 patients across 11 UK hospital sites over the past 3 months. To help ensure timely completion of study enrolment, the ARCADIA trial is now expanding with the addition of approximately 23 new hospital sites over the coming weeks. In addition to 4 new sites in the UK, up to 19 sites are to be opened in Czech Republic and Romania. Regulatory and ethics committee approval for both new countries was received at the end of December 2020 and the first patients from Czech Republic and Romania are expected to be recruited to ARCADIA before the end of January 2021.
Both Czech Republic and Romania have a high prevalence of diabetes (10.2% and 8.8% of the population having diabetes respectively), this compares with around 6.5% of people in the UK. In addition, both countries have regularly reported over 100 deaths from COVID-19 per day throughout December, indicating a high unmet clinical need.
The decision and rapid action to obtain approval in Romania and Czech Republic is testament to the strength of the St George Street team and its collaborative relationships with its development partners. St George Street is delighted to have received such rapid regulatory approval in the two new countries and looks forward to collaborating closely with the investigational teams in both countries.
The mechanism of actions of AZD1656, both blood glucose lowering and potential immunomodulatory action, are independent of viral mutations. AZD1656 activates glucokinase, which is expected to increase the migration of T regulatory cells in addition to reducing blood glucose. Reducing hyperglycaemia (high blood glucose) is increasingly seen to be important to improve outcomes in people with diabetes and COVID-19. Migration of regulatory T cells is expected to dampen down the hyperinflammation seen in the lungs for instance, that results in severe COVID-19.
Dave Tapolczay, CEO of St George Street said ‘I am delighted with the progress of the ARCADIA trial so far in the UK and through adding an additional 23 hospital sites we expect to see a significant impact on patient recruitment of the trial. Credit must go to the team in obtaining regulatory approval so quickly in Czech Republic and Romania. As a society we will need many solutions to battle the surging pandemic and I am proud that here at St George Street we are playing our part in helping to find those solutions.’
About Vela Technologies
Vela Technologies (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. More recently, Vela Technologies has also started to focus on existing listed companies where valuations may offer additional opportunities.
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