The phase 3 COMET-ICE trial will evaluate the safety and efficacy of a single intravenous infusion of VIR-7831 versus placebo, in nearly 1,300 participants
GlaxoSmithKline (GSK) and its partner Vir Biotechnology have expanded the clinical evaluation of their investigational Covid-19 treatment VIR-7831 to begin Phase 3 trials.
The Phase 3 study, dubbed Covid-19 Monoclonal antibody Efficacy Trial – Intent to Care Early (COMET-ICE), is designed to evaluate VIR-7831 in patients at elevated risk of hospitalisation due to Covid-19.
The late-stage clinical trial is planned to evaluate the safety and efficacy of a single intravenous infusion of VIR-7831 when compared to placebo, in nearly 1,300 non-hospitalised participants.
The percentage of patients with progression of Covid-19, as defined by the need for hospitalisation or death within 29 days of randomisation is the primary efficacy endpoint. The interim analyses are planned to evaluate the safety, futility and efficacy of the drug.
The results for the primary endpoint are expected in the first quarter of 2020, and results of interim analyses by the end of 2020.
The decision to begin the late-stage trials was based on positive safety data from the COMET-ICE study, submitted by an Independent Data Monitoring Committee on 30 September, 2020.
The clinical study is planned for expansion into additional sites in North America, South America and Europe.
GSK chief scientific officer and R&D president 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 3 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.”
Vir and GSK jointly developed the potential early Covid-19 treatment VIR-7831
VIR-7831, also known as GSK4182136, is a fully human monoclonal antibody, capable of neutralising the SARS-CoV-2 live virus. It was developed as part of collaboration between Vir and GSK, initiated in April 2020.
The drug has been designed to neutralise the virus, kill infected cells, provide a high barrier to resistance, and enhance the bio-availability of lungs, said the company.
The collaboration leveraged Vir’s own monoclonal antibody platform technology to develop existing and identify new anti-viral antibodies, and GSK’s expertise in functional genomics, to address the Covid-19 pandemic.
Also, the partnership combined the capabilities of both the companies in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes.
Furthermore, the COMET clinical development programme includes two more clinical trials, the first to study the treatment of hospitalised patients and another for the prevention of symptomatic infection.
The companies will also start a Phase 1b/2a trial of VIR-7832, a similar second investigational SARS-CoV-2 neutralising antibody similar to VIR-783, in addition to enhanced effector function, in late 2020.
Vir chief executive officer George Scangos said: “The rapid achievement of this important milestone reflects the urgency with which we’re mobilising our resources in the hope of preventing the worst consequences of this deadly virus.
“VIR-7831 is an antibody with characteristics that may enable it to prevent hospitalisation or death via multiple mechanisms. We look forward to continuing to collaborate with GSK to accelerate its development.”