Vir Biotechnology, Inc. and GlaxoSmithKline plc announced an agreement with the U.K.-based AGILE initiative to evaluate VIR-7832 in patients with mild to moderate COVID-19 in a Phase 1b/2a clinical trial. VIR-7832 is a neutralising COVID-19 antibody that preclinical data suggests has two distinguishing properties: an enhanced ability to clear infected cells and the potential to enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.
The AGILE trial platform, which will be the first to test VIR-7832 in humans, uses adaptable protocols and statistical models to enable the evaluation of candidate medicines for COVID-19 treatment. The initiative is a collaboration between the University of Liverpool, Liverpool School of Tropical Medicine, Liverpool University Hospitals NHS Foundation Trust, University of Southampton and Lancaster University and coordinated by the National Institute for Health Research Southampton Clinical Trials Unit across the UK Clinical Research Facility Network. The trial is due to begin in the first quarter of 2021.
George Scangos, Ph.D., Chief Executive Officer of Vir, said: “We are pleased to have the support of the NHS behind our efforts to evaluate and advance VIR-7832 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 this monoclonal antibody increase its potency and stimulate a T cell response to not only provide therapeutic benefits but also potentially confer a vaccine-like effect that could be applicable to prophylaxis.”
Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “While vaccine development has been very successful, current infection and hospitalisation rates show that multiple vaccines and therapeutic options will be needed to combat and ultimately end this pandemic. We are grateful to everyone involved in the AGILE study for supporting this important research and expect initial results from the study to provide important insights into the use of VIR-7832 early in the course of infection with SARS-CoV-2.”
VIR-7832 is set to become the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment. The first antibody, VIR-7831, is currently being investigated in two global phase 3 studies; for the early treatment of COVID-19 in patients who are at high risk of hospitalisation, and for the treatment of hospitalised patients with COVID-19.
Phase 1b/2a AGILE study design
AGILE is a randomised, controlled, multi-centre, seamless, adaptive Phase 1b/2a platform for the rapid evaluation of candidates of COVID-19 treatment in hospitalised patients and also in the community with early disease. The AGILE platform will assess VIR-7832 and VIR-7831 in adult outpatients with mild to moderate COVID-19 infection. The dose-escalation Phase 1b part of the study will evaluate the safety and tolerability of a single dose of VIR-7832 given by intravenous (IV) infusion and determine the dose for evaluation in the Phase 2a part of the study. A total of 24 study participants will be randomised 3:1 to VIR-7832 or placebo. The Phase 2 part of the study will include three treatment arms: 50 patients randomised to VIR-7832, 50 patients to VIR-7831, and 25 patients to placebo. The co-primary endpoints are safety and virologic activity of VIR-7832 as assessed by a change in SARS-CoV-2 viral load from baseline to Day 8. The Phase 2 part of the study also will assess the T cell responses to SARS-CoV-2 of VIR-7832 and VIR-7831. The trial is being conducted at up to five sites in the UK.