Vir And Glaxo Start Phase 2/3 Trial For COVID-19 Antibody Treatment
Vir Biotechnology Inc. and GlaxoSmithKline plc said Monday that they have commenced dosing of patients with VIR-7831 in the Phase 2/3 clinical study for their experimental COVID-19 antibody treatment.
The study will enroll about 1,300 patients worldwide who have early symptomatic infection. It will assess whether VIR-7831, as a single-dose monoclonal antibody, could prevent hospitalization due to the COVID-19.
George Scangos, chief executive officer,VIR, said, “This study is designed to demonstrate whether VIR-7831 can significantly reduce the need for hospitalization in high-risk individuals, such as the elderly or those with pre-existing conditions such as lung or heart disease.”
The companies expect that initial results could be available before the end of this year, with complete results expected in the first quarter of 2021, and potentially early access to the antibody treatment as soon as the first half of 2021.
The clinical development program for VIR-7831 also includes two additional planned trials—one for the treatment of severely ill hospitalized patients and another for the prophylaxis of symptomatic infection.
GlaxoSmithKline said in April that it collaborated with Vir Biotechnology to research and develop potential treatments for COVID-19, and would invest $250 million in Vir.
The companies expect to start a phase 2 trial of their other investigational SARS-CoV-2 neutralizing antibody, VIR-7832, later this year. VIR-7832 shares the same characteristics as VIR-7831 but may also function as a therapeutic and/or prophylactic T cell vaccine.
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