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Vir Biotechnology and GSK Start Phase 2/3 Study of COVID-19 Antibody Treatment
Phase 2/3 COMET-ICE study will investigate the safety and efficacy of antibody treatment in preventing hospitalization due to COVID-19 Potential for initial
About this update from Vir Biotechnology, Inc.
[{"type":"text","content":"Phase 2/3 COMET-ICE study will investigate the safety and efficacy of antibody treatment in preventing hospitalization due to COVID-19 Potential for initial study results to be available before the end of 2020, with early access to the antibody treatment as soon as the first half of 2021 SAN FRANCISCO and LONDON, Aug. 31, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) announced that the first patient was dosed last week in a Phase 2/3 study with VIR-7831 (also known as GSK4182136), a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalization.\n The aim of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) study, which will enroll approximately 1,300 patients worldwide who have early symptomatic infection, 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, 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. Last week’s initiation of the study follows the signing of a collaboration between the two companies in April 2020 to research and develop solutions for coronaviruses. George Scangos, Ph.D., chief executive officer, Vir, said: “Treating those with early COVID-19 disease so that it doesn’t become worse is critical both for the patients and for society. 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.” Dr. Hal Barron, chief scientific officer and president R&D, GSK, said: “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. This study will assess the ability of VIR-7831 to prevent high-risk individuals from...