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The University of Southampton

Southampton Clinical Trials Unit to test new ground-breaking COVID-19 antibody therapies

Published: 12 January 2021
COVID molecule

Researchers at the NIHR Southampton Clinical Trials Unit are helping to deliver first-in-human clinical trials of a new therapy which it is hoped could be used to treat people with COVID-19, as part of the ground-breaking AGILE trial platform.

The trial is being funded by over £3m of investment from GlaxoSmithKline and Vir Biotechnology who have joined forces with researchers from the Universities of Southampton and Liverpool who are leading early phase trials to test new treatments for COVID-19.

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.

George Scangos, PhD, CEO of Vir Biotechnology, said: “We are pleased to partner with the NHS to evaluate and advance our monoclonal antibodies for the treatment and potential prevention of COVID-19. This study will be critical to our efforts as we work to understand whether the modifications we have made to VIR-7832 increase its potency and stimulate a T cell response. If successful, VIR-7832 would bring treatment benefits and potentially confer a vaccinal effect that could be important for therapy and prophylaxis.”

This is the second therapeutic trial within the UK government supported AGILE drug testing platform launched last summer. This ground-breaking collaboration between the University of Liverpool, Liverpool School of Tropical Medicine, NIHR Liverpool and Broadgreen Clinical Research Facility, the NIHR Southampton Clinical Trials Unit at the University of Southampton, Lancaster University and the UK Clinical Research Facility Network10 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 Gareth Griffiths , Director of the NIHR Southampton Clinical Trials Unit , said: “We are incredibly excited to be adding these two new therapies into the AGILE trial. The COVID-19 vaccination programme has brought much hope that we will bring this virus under control, but it will take time. We therefore need to continue to find safe and effective treatments for people who will unfortunately get COVID-19 and the AGILE platform is a major part of this.”

Professor Saye Khoo, Chief Investigator for the trial at the University of Liverpool, 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’.”

Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “We are proud to being working with the Universities of Liverpool and Southampton to initiate the first-in-human study of VIR-7832. This study underscores our commitment to advancing our COVID-19 monoclonal antibodies across a range of settings from prevention through treatment. We expect initial results from the AGILE study to provide important clinical insights into the use of VIR-7832 early in the course of infection with SARS-CoV-2.”

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.

The Southampton Clinical Trials Unit (CTU) is a National Institute for Health Research (NIHR) supported CTU with expertise in the design, conduct and analysis of multicentre, interventional clinical trials. The CTU is based within the University of Southampton with offices at the University Hospital Southampton NHS Foundation Trust Southampton General Hospital site.

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