GSK House, Brentford, UK. Credit: GSK.

GlaxoSmithKline (GSK) and Vir Biotechnology have announced an agreement with the UK-based AGILE initiative to conduct Phase Ib/IIa clinical trial of a monoclonal antibody, VIR-7832, in mild to moderate Covid-19 patients.

Preclinical data of the neutralising Covid-19 antibody showed that it can potentially inhibit viral entry into healthy cells and has improved the ability to clear infected cells.

The randomised, controlled, multi-centre, seamless, adaptive trial to rapidly analyse Covid-19 treatment candidates in hospitalised patients and community with early disease.

The AGILE platform will evaluate VIR-7832 and another dual-action monoclonal antibody, VIR-7831, in adult outpatients with mild to moderate Covid-19.

The dose-escalation Phase Ib part will assess the safety and tolerability of a single intravenous dose of VIR-7832 and determine the evaluation dose for the Phase IIa part.

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It will enrol 24 subjects who will be randomised into 3:1 ratio to receive either VIR-7832 or placebo. The Phase II part will have three treatment cohorts with 50, 50 and 25 patients receiving VIR-7832, VIR-7831 and placebo, respectively.

VIR-7832’s safety and virologic activity assessed by a change in SARS-CoV-2 viral load from baseline to day eight will form the trial’s co-primary endpoints.

T-cell responses of the two antibodies to SARS-CoV-2 will be evaluated in the Phase II part.

The trial is set to begin in the first quarter of this year in up to five sites in the UK.

Vir CEO 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.”

Last September, GSK and Vir started dosing participants in a Phase II/III trial of VIR-7831 as a potential early treatment for Covid-19 patients at high hospitalisation risk.