GlaxoSmithKline (GSK) and Vir Biotechnology have expanded the phase 3 study of their COVID-19 antibody into additional sites in North America, South America and Europe.
The phase 3 COMET-ICE trial is evaluating the monoclonal antibody – VIR-7831 – for the early treatment of COVID-19 patients who have a high-risk of hospitalisation.
VIR-7831 has previously demonstrated the ability to neutralise the SARS-CoV-2 virus, which causes COVID-19, both in vitro and in vivo.
The study has been expanded into a number of additional sites following a positive assessment of unblinded safety data from an initial group of volunteers in the trial.
The primary endpoint of the COMET-ICE study is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalisation or death within 29 days of randomisation.
The results for the primary endpoint are expected to become available in the first quarter of 2021, with current estimates from GSK/Vir Biotech angling for January 2021.
In addition to this trial, the COMET clinical development programme for VIR-7831 includes another two trials – one for the treatment of hospitalised COVID-19 patients and one for the prevention of symptomatic infection.
GSK and Vir Biotech are also planning to launch a phase 1b/2a trial in late 2020 evaluating another SARS-CoV-2 neutralising monoclonal antibody, VIR-7832.
In April 2020, GSK and Vir Biotech entered into a collaboration agreement for the research and development of solutions for coronaviruses, including SARS-CoV-2.
The collaboration combines Vir Biotech’s monoclonal antibody platform technology with GSK’s expertise in functional genomics and capabilities in CRISPR screening to identify anti-coronavirus compounds.
Vir Biotech has also signed a deal with Biogen for the process development and manufacturing of its antibodies for COVID-19.
Under this agreement, Biogen will perform process development activities and specified manufacturing, as well as process transfer services, to enable commercial supply of Vir Biotech’s SARS-CoV-2 monoclonal antibodies.
The Biogen agreement builds on Vir Biotech’s additional manufacturing agreements with China-based WuXi Biologics and Incheon, South Korea-headquartered Samsung Biologics.
A number of companies are currently seeking to develop antibodies for COVID-19, with the most notable likely being Regeneron.
The first descriptive analyses of Regeneron’s investigational COVID-19 antibody cocktail, REGN-COV2, showed that the treatment was able to reduce viral load and help non-hospitalised patients to recover faster. On top of that, REGN-COV2 also showed positive trends in reducing medical visits.
REGN-COV2 has entered the global spotlight over the last week after reports that US President Donald Trump received the treatment after testing positive for the SARS-CoV-2 virus last week.