Vir Biotechnology (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) announced that they have started dosing patients in a phase 2/3 clinical trial of VIR-7831 (or GSK4182136, as it's also known), a monoclonal antibody for early treatment of COVID-19 patients to prevent the disease from worsening.
The study, named COMET-ICE, will enroll 1,300 patients worldwide with mild or moderate COVID-19 who are at high risk of progression to severe symptoms. The non-hospitalized patients in the double-blind trial will receive either a placebo or a single intravenous infusion of VIR-7831. The primary endpoint of the study will be the number of patients who worsen as defined by death or the need for hospitalization within 29 days. The companies expect early results before the end of the year, complete results in the first quarter of 2021, and early availability of the treatment in the first half of next year.
VIR-7831, a product of the collaboration between the British drug giant and the San Francisco-based biotech, is a monoclonal antibody that's been designed to mimic antibodies that have been isolated from COVID-19 survivors and enhanced for longer life, and that can enhance bioavailability in the lungs. The companies expect the to neutralize the SARS-CoV-2 virus, preventing it from infecting new cells while also stimulating the immune system to eliminate infected cells.
Vir and GSK also plan to start a phase 2 trial later this year of a second antibody candidate, VIR-7832, that has similar characteristics to VIR-7831 but could also have preventative effects that would allow it to be used as a vaccine.