Vir Biotechnology and GlaxoSmithKline dosed the first patient last week in a phase 2/3 study with its COVID-19 treatment.
The treatment, VIR-7831, is a fully human anti-SARS-CoV-2 monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalization. Monoclonal antibodies that neutralize the virus that causes COVID-19 are being investigated as a potential therapeutic and prophylactic approach against the disease. Vir’s antibody platform has identified unique antibodies from survivors that may work by blocking the virus from infecting new cells and by recruiting the immune system to eliminate infected cells.
The study will enroll approximately 1,300 patients worldwide who have early symptomatic infection. The aim is to assess whether VIR-7831, as a single-dose monoclonal antibody, can prevent hospitalization due to COVID-19. Initial results may be available before the end of this year, and complete results expected in the first quarter of 2021. In addition, early access to the antibody treatment could be ready as soon as the first half of 2021.
“Treating those with early COVID-19 disease so that it doesn’t become worse is critical both for the patients and for society,” George Scangos, CEO, Vir, said. “Hospital systems are overwhelmed worldwide, with new infections continuing to strain already limited resources. 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 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.
“Monoclonal antibodies directed against the SARS-CoV-2 virus could provide an effective and immediate immune response to COVID-19, bypassing the need for our body to produce its own antibodies, which is particularly important in the absence of an effective vaccine,” Dr. Hal Barron, chief scientific officer and president R&D at GSK, said.” This study will assess the ability of VIR-7831 to prevent high-risk individuals from progressing to severe disease, and in future studies, we will also test the antibody’s ability to prevent infection in high-risk patients and to reduce disease severity in patients who are already hospitalized.”
Later this year, both of these companies expect to start a phase 2 trial of their other investigational SARS-CoV-2 neutralizing antibody, VIR-7832. It shares the same characteristics as VIR-7831 but may also function as a therapeutic and/or prophylactic T cell vaccine.