Two new drug therapies are to be studied in patients as part of the ground-breaking AGILE clinical trial platform, with the hope of finding treatments for people with COVID-19.
The trial is being funded by over £3m of investment from GlaxoSmithKline and Vir Biotechnology who have joined forces with researchers from the Universities in Liverpool and Southampton who are leading early phase trials to test new treatments for COVID-19 in partnership with LSTM.
The two monoclonal antibody therapies, VIR-7831 and VIR-7832, will be given to patients who have tested positive for COVID-19 and have mild or moderate symptoms. Pre-clinical studies of these antibody therapies have already demonstrated promising results in combatting coronavirus infections. While VIR-7831 is currently being evaluated in two Phase 3 clinical trials, the AGILE study marks the first in-human trial of VIR-7832.
This is the second therapeutic trial within the UK government supported AGILE drug testing platform. This ground-breaking collaboration between LSTM, the University of Liverpool, NIHR Liverpool and Broadgreen Clinical Research Facility based at the Royal Liverpool University Hospital, the NIHR Southampton Clinical Trials Unit at the University of Southampton, Lancaster University and the UK Clinical Research Facility Network aims to rapidly identify therapies that have the potential to be used to treat COVID-19 patients and bring them into early phase clinical trials.
Professor Saye Khoo from University of Liverpool is Chief Investigator for the trial. He said: “A number of monoclonal antibodies are being studied for treatment of COVID-19, each different in its own way. The potential for VIR-7832 to not only bind SARS CoV-2, but also to stimulate the immune system is a unique feature, and we are very keen to study whether this confers any additional treatment benefit’.”
LSTM’s Dr Tom Fletcher, AGILE international lead, said: “The aim of AGILE is to rapidly evaluate new treatments for COVID-19, including drugs that try to prevent patients with the infection ending up in hospital, which is clearly extremely important at this point. It is great to be working in such a productive partnership and initiating the first in-human study of VIR-7832. Along with social distancing and the vaccine roll-out, early treatment of the virus is key to controlling it, and hopefully returning to some sort of normality in the future.”
Dr Richard Fitzgerald, Director of the NIHR Liverpool and Broadgreen Clinical Research Facility, said: “We are really pleased to be able to take this trial forward in our Clinical Research Facility, an MRHA accredited unit with a vast experience of conducting first-in-human trials, and we are looking forward to expanding this trial into other CRF sites across the UK in the coming months with support from the MRC.”
The AGILE trial platform was launched in July 2020, and the first treatment in the drug testing platform entered into patient trials in Liverpool in September.