VIR-7832 is the second monoclonal antibody from Vir-GSK collaboration, and the study is expected to commence in Q1 2021 across multiple UK sites
Vir Biotechnology and GlaxoSmithKline (GSK) have agreed with the UK-based AGILE initiative to study their Covid-19 treatment VIR-7832 in a Phase 1b/2a trial.
AGILE 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.
Also, the initiative is coordinated by the National Institute for Health Research Southampton Clinical Trials Unit across the UK Clinical Research Facility Network.
The Phase 1b/2a clinical trial is expected to commence in the first quarter of 2021, through AGILE clinical trial platform to test the VIR-7832 in first humans.
AGILE is a randomised, controlled, multi-centre, adaptive Phase 1b/2a platform that leverages adaptable protocols and statistical models to help evaluate the drug candidates for the treatment of Covid-19 in hospitalised patients.
Vir chief executive officer George Scangos 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.”
VIR-7832 is a dual-action monoclonal antibody, capable of clearing infected cells and enhance virus-specific T cell function, to help treat or prevent Covid-19 infection.
The drug is said to be the second monoclonal antibody from the Vir-GSK collaboration, while the first antibody VIR-7831 is currently being investigated in two global phase 3 studies.
AGILE platform is planned to evaluate VIR-7832 and VIR-7831 in adult outpatients with mild to moderate Covid-19 infection.
The co-primary endpoints of the study include safety and virologic activity of VIR-7832, determined by a change in SARS-CoV-2 viral load from baseline to Day 8.
The collaboration between clinical-stage immunology company Vir Biotechnology and global health technology firm GSK initially began in April 2020, to develop solutions for Covid-19.
Vir-GSK partnership leverages monoclonal antibody platform technology to advance the existing and identify new anti-viral antibodies with the potential to serve as Covid-19 therapies.
GSK chief scientific officer and R&D president Hal Barron 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.”