St George Street Capital is a new type of charity, sourcing investment to fast track clinical trials, so we can get new treatments as quickly as possible to the people who need them.
Thousands of treatments with powerful potential are currently stalled in the system, keeping patients suffering needlessly – sometimes for decades.
Our mission is to apply bold new thinking and lateral approaches to unlock all this therapeutic potential faster and transform the lives of patients and their families.
We don’t expect to achieve a revolution alone. We’re working collaboratively with all kinds of people and organisations in the field, in the UK, US and in China. We want to change the game around existing treatment development. Because we believe when you can change your thinking, you can change the way millions of patients are treated today.
Established in 2017, St George Street Capital brings together a powerful mix of expertise, from investors and business managers to clinical scientists and researchers.
Our key people include:
Chairman. Professor of Cardiovascular Medicine, University College Medicine.
Trustee. Professor of Ocular Biology and Therapeutics, UCL Institute of Ophthalmology.
Trustee. Clinical Pharmacologist and Consultant Physician.
Head of Strategy and Operations.
Head of Clinical Development.
Elin Haf Davies
Consultant. Great Ormond Street Hospital, Institute of Child Health (UCL), EMA, Aparito.
PA to CEO
Idiopathic Male Infertility
In 2021 St George Street is looking to start a Phase Ib clinical trial in Idiopathic Male Infertility, PRIMER. Male infertility is a completely neglected area of the pharmaceutical industry, however 1 in 7 couples will experience infertility and in 50% of these cases male factor infertility is a significant cause. ‘Idiopathic’ (or unexplained) is the diagnosis given to around half of all men with male infertility. The only proven treatment for idiopathic male infertility at present involves artificial reproductive technologies (ART), specifically a specialised form of IVF called ICSI. This is extremely invasive for the woman involving multiple weeks of high dose hormone self-injection, multiple intravaginal scans and egg harvesting. In the UK right now, the number one reason why couples require IVF therapy is actually male infertility, not female infertility. St George Street is looking to change this treatment paradigm, with a new therapy that looks to treat male factor infertility directly. The proposed Ph Ib trial is expected to involve around 40 patients who will be given an oral tablet for 10 days to investigate the biological mechanism of this oral therapy in blood and semen in men with Idiopathic Male Infertility. Here at St George Street, we passionately believe in the need for such a treatment with a huge community of both men and women calling for new treatments. We know that current treatments using ART come at a high financial and mental-health cost. We want to change that. Keep up to date with our progress through our website and twitter account @st_capital.
In addition, we will be working to progress treatments for the following conditions:
- — Pulmonary hypertension
- — Spinal cord injury
- — Nonalcoholic Steatohepatitis
- — Sickle cell disease
- — Glioma
- — DME
- — Pulmonary sarcoidosis
Covid-19 Trial Update - 09/09/2021
Results from ARCADIA Phase II Clinical Trial of A Potential Therapy for COVID-19
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.”
TRIAL INITIATED TO TEST POTENTIAL NEW COVID-19 TREATMENT FUNDED BY UKRI GRANT AND EML
A new therapy that could treat people with diabetes suffering from COVID-19 is to undergo an advanced clinical trial in the UK.
The Medicines and Healthcare products Agency (MHRA) has approved the trial following new preclinical research that suggests a glucose kinase activator (AZD1656) could help diabetes sufferers infected with coronavirus by dampening the overactive response of the immune system typically acute in those patients with raised blood glucose levels. The trial will involve hospitalised patients with mild to moderate COVID-19 symptoms and if successful the compound could ultimately be prescribed by a GP for people with diabetes presenting with early COVID symptoms.
People living with diabetes face a significantly higher risk of dying with COVID-19. One in three of all deaths with COVID-19 in hospital in England have been associated with diabetes. Diabetes, whether type 1 or 2, has been the leading single cause of co-morbidity during this pandemic. People living with type 1 diabetes are at three and a half times the risk, and people living with type 2 diabetes are at double the risk of dying in hospital with the virus compared to people without diabetes. Learn more.
This exciting new development, believed to be unique among the hundreds of COVID-related research projects around the world today, was arranged and structured by Professor Sir Chris Evans, Chairman and CEO of Excalibur Healthcare Services, through a new vehicle, Excalibur Medicines Ltd, which brought together the scientific intellectual property, international funding and a world leading team to drive the project forward. The idea of investigating AZD1656 in this setting was conceived by Professor John Martin and his team at St George Street, a UK-based biomedical research charity. The drug was originally developed for another indication by Astra Zeneca, who have agreed to provide the drug substance for the trial, while St George Street will lead the clinical trial.
The trial, named ARCADIA, will commence with Professor Evans and the Excalibur team having sourced investment from Mubadala of Abu Dhabi, one of the world’s leading sovereign wealth funds, Excalibur itself and several high net worth individuals. This is in addition to funding secured from the UK Government through the UKRI / Innovate UK programme. This enables the trial to go ahead at speed in 150 patients over a 4 month timeframe at multiple sites in the UK.
Professor Evans said: “All of us supporting this trial recognise this drug has the potential to make a huge difference to people with diabetes who are unfortunate enough to contract coronavirus and we foresee a significant impact on the level of fatalities in the future. Treatments such as this could be vital as we are likely to be living with this horrific virus for some time to come.”
David Tapolczay, CEO St George Street, said: “Given the current crisis, we have paused all our current research programmes to focus totally on this clinical trial and evaluate this potentially life-saving new drug. Our charity was set up to accelerate the delivery of treatments to patients and this ethos is needed now more than ever before. We want to do everything in our power to ensure patients recover from this terrible virus.”
Professor John Martin, Chairman of the charity and Principal Investigator on the grant awarded by UKRI, said: “Novel research thinking in an interdisciplinary group combined with the drive of the charity and the excellent relationship we have with Astra Zeneca have produced the potential for a great therapeutic leap. This also has potential for non-diabetic patients with COVD-19.”
NOTES TO EDITORS
Mechanism of Action:
In many patients with severe reaction to coronavirus infection, an overreaction of the body’s own immune system can cause severe problems including damage to the lungs and heart. This leads to breathing problems that might necessitate intubation and ventilation. AZD1656 has been shown to activate the migration of T regulatory cells to sites of damaging inflammation in preclinical experiments. Migration of T regulatory cells amplifies the body’s own mechanism of damping down an inappropriate inflammatory overreaction. T regulatory cells are also very important in the tissue repair process. AZD1656 has already undergone Phase ll trials for use in type 2 diabetes and is also currently under clinical investigation for renal transplant rejection in the UK.
St George Street believes this research into T regulatory cells shows AZD1656 could be of potential benefit for people with diabetes who have COVID-19. In addition, AZD1656 has been proven to be effective in reducing blood glucose levels over a 4-month period in previous clinical studies. Blood glucose control is thought to be an important predictor of mortality, with research reporting that patients with diabetes with poor blood glucose control had a greater mortality from COVID-19 than those with good glucose control. Elevated blood glucose, for instance, can increase glucose levels in airway secretions which can lead to increased viral replication in the lungs. Hence the potential treatment could have a dual mode of action that would be particularly helpful for COVID-19 patients with diabetes. It also has a clean safety profile having been already in twenty-five trials for another indication in almost a thousand patients.
The initiation of this clinical trial forms part of an existing collaboration between St George Street and AstraZeneca as part of its Open Innovation programme (www.openinnovation.astrazeneca.com).
About AZD1656 (Glucokinase activator):
AZD1656 has been shown to be a potent, selective, activator of glucokinase and reduces plasma glucose levels in preclinical experiments and in diabetic patients over four months. AZD1656 has been studied in clinical trials as a single dose up to 180 mg and multiple doses to 150 mg twice-daily for 8 days in healthy volunteers, as well as alone and in combination with other blood glucose control agents in patients with diabetes at 200 mg daily for up to 6 months duration. In both healthy volunteers and patients with diabetes, no significant safety concerns were noted.
About St George Street:
St George Street is a biomedical research charity on a mission to fast-track clinical trials so we can get new treatments as quickly as possible to the people who need them. We apply bold new thinking to unlock the therapeutic potential of therapies and science currently sitting on the shelf in pharma. We are a new type of charity, sourcing investment to accelerate clinical trials, where new science shows great potential and where patients and clinicians are calling out for treatments. St George Street was established in 2017 and brings together a powerful mix of expertise, from investors and business managers to clinical scientists and researchers.
If you are a doctor treating hospitalised COVID-19 patients in the UK and would like information on how to take part in the study please contact firstname.lastname@example.org