A major clinical trial platform designed for the rapid clinical evaluation of potential COVID-19 treatments has received a multi-million pound funding boost to aid its expansion.
The AGILE testing platform, co-led by researchers at the NIHR Southampton Clinical Trials Unit at the University of Southampton, has received £3.2m from the UK government’s Department of Health and Social Care to fast track the clinical trials of innovative treatments against the coronavirus.
Awarded by the Medical Research Council and co-funded through the National Institute of Health Research (NIHR), this new money will allow AGILE’s activity to be expanded nationally into five UK centres, and complements funding from the Wellcome Trust and UNITAID in addition to funding announcements from industry.
AGILE is a UK phase 1 and 2a clinical trial platform designed for rapid clinical evaluation of potential COVID-19 treatments. 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.
AGILE is a collaboration between the University of Liverpool, Liverpool School of Tropical Medicine (LSTM), the NIHR Southampton Clinical Trials Unit, Lancaster University and Liverpool University Hospitals NHS Foundation Trust as well as other partners.
Professor Gareth Griffiths, Director of the NIHR Southampton Clinical Trials Unit, said: “We are delighted to receive this funding which will allow us to expand the AGILE platform across the UK CRF network and take more potential COVID-19 treatments through early phase clinical trials.
“Many existing later phase trials for COVID-19 are looking at repurposing drugs that are already in use for other diseases. But the AGILE platform provides a pipeline for fast-tracking novel therapies through early phase trials to test their safety and potential efficacy. If these new therapies show potential benefit in combatting COVID-19, they can then be moved quickly into the existing later phase trial platforms for further testing.
“The innovative design of the AGILE platform means we are able to put several different treatments through early phase trials at the same time. This will speed up the trial process and hopefully bring new treatments into standard care more quickly, benefitting COVID-19 patients in the future.”
Professor Saye Khoo, Chief Investigator at the University of Liverpool, said: “What we really need is the seamless progression of promising new drugs for treating COVID-19 through pre-clinical development to early phase trials and thereafter onto large-scale efficacy studies.
“AGILE is the vital link in this chain, harnessing the strengths of academic-industry partnerships, proving once again that the NHS through its research networks and infrastructure is world-leading for pandemic research.”
Dr Tom Fletcher, AGILE’s international lead at LSTM, said: “This is great news and a huge vote of confidence in the research conducted by the AGILE platform. It will enable us to test and evaluate several treatments in parallel. It will significantly speed up the process in a safe and responsible manner and ultimately benefit COVID-19 patients both in the UK and internationally with effective treatments.”
Four treatments have so far been selected for AGILE – EIDD-2801 (Molnupiravir), an antiviral; VIR-7831 and VIR-7832, both monoclonal antibodies; and Nitazoxanide, an antiprotozoal.
The first patients were recruited into AGILE in September in partnership with Royal Liverpool University Hospital Clinical Research Unit.
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.A video explaining the AGILE platform is available here.