Vela Technologies Regulatory News (VELA)

18 December 2020

Vela Technologies plc

("Vela" or "the Company")

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

The Board of Vela notes the update published yesterday by St George Street Capital Limited ("SGS") regarding the progress of its ARCADIA clinical trial to test SGS002 ("the Asset"), a drug that could be beneficial to diabetic patients suffering from COVID-19.

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:

The ARCADIA clinical trial is progressing very well, having recruited its first patient at the end of September. As of 13th December, 47 patients had been enrolled in the trial across 9 of our 11 UK hospital sites currently contracted. There are 4 further hospital sites being initiated week commencing 14th December to bolster recruitment. The current sites are spread throughout England with 5 of them in London and the South East. The trial aims to enrol 150 patients and the original plan was to recruit all of these from 15 sites in the UK. However, there was a dramatic fall-off in cases over the summer, for instance in the first two weeks of September there were no COVID-19 patients at all in some of our sites. This led SGS to the decision to evaluate the option of opening up sites in other countries. Ten additional countries were surveyed for suitability to open trial sites, taking into account the number of cases in the country (actual and forecast), the ability to manage and monitor a trial there, the appetite of the regulatory authorities, the presence of other clinical trials competing for patients, and the ability to deliver the drug there safely. As a result of that, SGS is at the final stages of initiating new trial sites in Romania and the Czech Republic including negotiating contracts and gaining regulatory approval. Additionally, the enrolment period of the trial has been extended so that patients can be accepted onto the trial until the end of February. At that time, or before if recruitment in the new countries goes quickly, all patients will have been dosed and the data collected in the trial will be locked down for a month while it is independently assessed and a report published.

The trial is completely randomised and double-blinded with a placebo arm, meaning that no clear data can be seen until the report is published. We note however that the drug is well tolerated with no safety concerns raised in previous trials of over 960 patients. The Chief Investigator in the trial is Dr Kieran McCafferty, specialist in diabetic nephrology at Barts NHS Trust and Queen Mary University.

Dave Tapolczay, CEO of SGS said "We are delighted with the progress of the ARCADIA trial. Obviously the news that we will shortly have vaccines available is very welcome, but it doesn't remove the need for treatments for COVID-19, especially for those with underlying conditions such as diabetes. In some cases, the vaccines will not be suitable for people with those conditions, in other cases the vaccine may not be 100% effective. Add to this the fact that uptake and supply of the vaccine may not be optimal, and it is highly likely that treatments will be needed for many years to come. Nobody should assume there will be only one way out of this pandemic. Certainly, big pharma companies want to offer a full suite of products for any disease area whether vaccine, prophylaxis, therapeutic, and for recovery. Unlike many other treatments AZD1656 is not virus specific, as it is activating cells within our own body. This gives the treatment an advantage over many other treatments, and potentially it could be used in other virally induced respiratory diseases including other mutations of coronavirus, MERS and pneumonia. This gives AZD1656 longevity as a treatment beyond the current pandemic. AZD1656 is an orally available tablet that is stable at room temperature, making it suitable for use around the world. Furthermore, should the trial be successful, we expect to agree a commercial deal with a partner almost immediately."

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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.