Groundbreaking COVID-19 treatments to be fast-tracked through clinical trials

• UK Government awards multi-million-pound funding to phase 1 clinical trial platform to fast-track innovative treatments
• NHS patients could receive cutting-edge COVID-19 treatments in months rather than years
• Move will bring in the world’s best researchers to trial treatments in the UK

The move marks a landmark development in COVID-19 research that could see results for brand new treatments in months rather than years, and will enable the government to get even more safe and effective treatments to the NHS rapidly through a more streamlined process.

Currently, the government funds phase 2 and 3 trials, such as the RECOVERY trial, which brought life-saving treatments dexamethasone and tocilizumab to the NHS. Phase 1 trials, usually arranged by the researchers, are the earliest stage of human trials that ensure treatments are safe and show a signal of benefit in treating a disease.

The funding has been awarded to expand the AGILE clinical trial platform and will allow for global innovators to progress cutting-edge treatments for COVID-19 through all 3 clinical trial phases in the UK, further protecting our supply chain. This in turn will attract the brightest of researchers and manufacturers from around the world to trial their medicines here in Britain.

Health and Social Care Secretary Matt Hancock said: “Today’s news will ensure all phases of clinical trials for new treatments are done in the UK, protecting our supply chain and securing the world’s best treatments for NHS patients at a much faster rate.

“I am immensely proud of the work that’s been undertaken by the brilliant scientists behind these treatments and the thousands of UK patients who have taken part in the trials.

“Together, we can continue to ensure the UK is one of the best countries in the world for trialling and deploying the most groundbreaking medical advancements for both COVID-19 and for dangerous diseases in the future.”

The funding has been awarded by the Medical Research Council (MRC) and co-funded though the National Institute for Health Research (NIHR).

A phase 1 trial is the earliest stage of human trials and is an essential first step that ensures treatments are safe. Once they pass phase 1, they then go into larger-scale phase 2 and 3 trials, such as RECOVERY or PRINCIPLE, before being made available on the NHS once proven to be effective.

The UK has proven throughout this pandemic to be a world leader in medical research and life sciences, stepping up quickly to the task of finding effective therapeutics for a completely new virus and supported by millions in funding by the UK government.

• AGILE is a UK phase 1 and 2a clinical trial platform designed for rapid clinical evaluation of potential COVID-19 treatments
• It is a collaboration between the University of Liverpool, the University of Southampton Research Unit, and other external partners
• The innovative design of the trial means that multiple potential treatments can be evaluated in parallel and important testing stages can be completed in months rather than years, while maintaining a high level of safety at all times
• Patients in early stages of COVID-19 infection will be recruited to AGILE from the community, in addition to patients who have been hospitalised with COVID-19
• Treatments that show a signal of benefit in AGILE will be rapidly considered for advancement into later phase clinical trial platforms, such as PRINCIPLE and RECOVERY, where the effectiveness of treatments can be proven in greater patient numbers
• The Therapeutics Taskforce will work with innovators to support them to progress their promising treatments through clinical trial phases
• 4 treatments have so far been selected for AGILE:
  • EIDD-2801 (Molnupiravir), an antiviral
  • VIR-7831 and VIR-7832, both monoclonal antibodies
  • Niclosamide, an anthelminthic
• Future treatments to enter AGILE will be selected by the UK COVID-19 Therapeutics Advisory Panel (UK-CTAP), who lead the process of reviewing and evaluating proposals for treatments to enter UK national trial platforms – read more about UK-CTAP and how drug proposals can be made
• The UK was the first in the world to find a treatment which was proven to significantly reduce the risk of death: dexamethasone, found through the government-funded RECOVERY trial
• On Thursday 11 February, RECOVERY also found the drug tocilizumab, when administered to hospitalised patients on oxygen with dexamethasone, further reduces the risk of death by 14% and length of hospital stay for patients by 5 whole days, on top of the benefits of dexamethasone – which will mean once rolled out to patients will significantly reduce pressures on the NHS
• REMAP-CAP, which also received government funding, last month published results showing tocilizumab reduced the length of time in hospital by 10 days when administered to patients with 24 hours of being admitted to intensive care