GlaxoSmithKline, along with Vir Biotechnology, has agreed with the UK-based AGILE initiative to assess VIR-7832 in patients with mild to moderate Covid-19 in a phase 1b/2a clinical study.
VIR-7832, a neutralising Covid-19 antibody, attaches to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1.
According to GSK, the preclinical data suggests that VIR-7832 has two distinguishing properties, including an enhanced ability to clear infected cells and the potential to improve virus-specific T cell function.
The AGILE trial platform is said to be the first to assess VIR-7832 in humans. It uses adaptable protocols and statistical models to facilitate the assessment of candidate medicines for Covid-19 treatment.
AGILE is a randomised, controlled, multi-centre, seamless and adaptive phase 1b/2a platform for the rapid assessment of candidates of Covid-19 treatment in hospitalised patients and also in the community with early disease.
GSK stated that the trial is slated to commence in the first quarter of 2021.
The platform will evaluate 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 assess 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.
AGILE trial’s co-primary endpoints include safety and virologic activity of VIR-7832 as evaluated by a change in SARS-CoV-2 viral load from baseline to day 8.
In addition, the phase 2 part of the study will evaluate the T cell responses to SARS-CoV-2 of VIR-7832 and VIR-7831.
GSK R&D president and chief scientific officer Dr Hal Barron said: “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.”
At present, the first antibody VIR-7831 is being assessed 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.
In October 2020, GSK and Vir Biotechnology have announced that they will expand the study of a VIR-7831 monoclonal antibody to treat Covid-19.
In April 2020, Vir and GSK have collaborated for the research and development of solutions for coronaviruses, including SARS-CoV-2.