British drugmaker GlaxoSmithKline (GSK) and Vir Biotechnology have announced that they will pause enrolment for the treatment arm of a phase 3 trial evaluating their investigational COVID-19 antibody VIR-7831.
VIR-7831 is a ‘dual-action’ monoclonal antibody (mAb) that has shown potential to both block viral entry into healthy cells and clear COVID-19 infected cells.
The US National Institutes of Health (NIH) sponsored ACTIV-3 trial is evaluating VIR-7831 in hospitalised adults with COVID-19.
Although VIR-7831 met the initial pre-specified criteria to continue to the next phase of the trial, early sensitivity analyses of the first 300 patients enrolled in the trial have ‘raised concerns’ over the potential benefit of the drug in this setting.
As a result, the independent data and safety monitoring board (DSMB) has recommended that enrolment for the VIR-7831 arm of the trial should be paused while the data matures.
“While we are disappointed with the recommendation of the DSMB, we are encouraged by the safety profile of VIR-7831 and by the possibility of a benefit on top of remdesivir and corticosteroids in this advanced cohort of patients,” said George Scangos, chief executive officer of Vir.
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.
In addition to the ACTIV-3 trial, GSK/Vir are evaluating VIR-7831 in the outpatient setting in the COMET-ICE and BLAZE-4 studies.
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.
This study was expanded into a number of additional sites last year, following a positive assessment of unblinded safety data from an initial group of volunteers in the trial.
The BLAZE-4 trial is testing a combination of Eli Lilly’s neutralising antibody bamlanivimab with VIR-7831 in low risk patients with mild-to-moderate COVID-19.
VIR-7831 has previously demonstrated the ability to neutralise the SARS-CoV-2 virus, which causes COVID-19, both in vitro and in vivo.
GSK and Vir Biotech are also planning to launch a phase 1b/2a trial evaluating VIR-7831 along with another SARS-CoV-2 neutralising mAb, VIR-7832, in adults with mild-to-moderate COVID-19.