GlaxoSmithKline (GSK) and Vir Biotechnology are set to globally expand the study of experimental antibody VIR-7831 for the early treatment of Covid-19 patients with a high risk of hospitalisation to Phase III.
The Phase III part of the COMET-ICE study will evaluate the safety and efficacy of a single intravenous infusion of VIR-7831 or placebo in around 1,300 non-hospitalised patients across the globe.
VIR-7831, which is also known as GSK4182136, is a fully human Severe Acute Respiratory Syndrome coronavirus-2 (antiSARS-CoV-2) monoclonal antibody.
It can neutralise the virus, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs.
The proportion of patients with progression of Covid-19 as defined by the need for hospitalisation or death within 29 days of randomisation, is the study’s primary efficacy endpoint.
On obtaining a positive analysis of safety and tolerability data from the Phase II lead-in last week, an Independent Data Monitoring Committee recommended progressing the trial to Phase III.
The results of interim analyses, which will access safety, futility and efficacy, are expected by end of the year.
The primary endpoint results are anticipated in the first quarter of next year.
Vir Biotechnology CEO George Scangos said: “VIR-7831 is an antibody with characteristics that may enable it to prevent hospitalisation or death via multiple mechanisms.”
VIR-7831 can potentially be used as outpatient treatment for Covid-19 if proven successful.
GSK chief scientific officer and R&D president Dr Hal Barron said: “Given the urgent patient need I am very pleased that we have progressed VIR-7831 from pre-clinical studies to a Phase III trial in only six months since announcing our collaboration with Vir.
“We believe this neutralising antibody’s high barrier to resistance, notable effector function, and enhanced delivery into the lung suggest it has best-in-class potential in the fight against this global pandemic.”
Apart from VIR-7831, the COMET programme includes a trial for the treatment of hospitalised patients and one for the prevention of symptomatic infection.