GlaxoSmithKline and Vir Biotechnology Begin Phase 2/3 Study of COVID-19 Monoclonal Antibody Treatment

(San Francisco, CA, USA) will investigate the safety and efficacy of antibody treatment in preventing hospitalization due to COVID-19.

The first patient has been dosed in the Phase 2/3 COMET-ICE 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. 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.

Monoclonal antibodies that neutralize SARS-CoV-2 infection, the virus that causes COVID-19, are being investigated as a potential therapeutic and prophylactic approach against the disease. They are produced, or cloned, from immune cells in a laboratory. Vir’s antibody platform has identified unique antibodies from survivors that may work by blocking the virus from infecting new cells (neutralization) and by recruiting the immune system to eliminate infected cells (effector function).

A key feature of SARS-CoV-2 is the spike protein that covers the virus’ outer surface. The virus uses these spike proteins to bind to and enter human cells, leading to infection. It is hypothesized that monoclonal antibodies directed against the spike proteins could represent a therapeutic approach against COVID-19. Pre-clinical studies with VIR-7831, which was identified through Vir’s antibody platform, showed affinity for the SARS-CoV-2 spike protein and high potency in neutralizing SARS-CoV-2, suggesting a high barrier to resistance and an ability to recruit immune cells to kill already infected cells. In addition, VIR-7831 has been designed to enhance lung bioavailability.

The COMET-ICE multi-centre, double-blind, placebo-controlled phase 2/3 study investigating VIR-7831 in patients with mild or moderate COVID-19 who are at high risk of progression to severe disease comprises two parts. The first part (the Lead-In phase) will serve as the first-in-human assessment. The Lead-In phase will assess the safety and tolerability of a single 500 mg intravenous (IV) infusion of VIR-7831 or placebo over a 14-day period in non-hospitalized patients. It aims to recruit 20 patients across the US. Following this initial safety assessment, the second part (the Expansion phase) will progress with the aim of reducing the need for hospitalization. The Expansion phase will assess the safety and efficacy of a single IV infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants globally. The primary efficacy endpoint is the proportion of patients with mild or moderate COVID-19 who worsen, as defined by the need for hospitalization or death, within 29 days of randomization. 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.

The COMET 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. Later this year, the companies expect to start a Phase 2 trial of their other investigational SARS-CoV-2 neutralizing antibody, VIR-7832, which shares the same characteristics as VIR-7831 but may in addition also function as a therapeutic and/or prophylactic T cell vaccine.

“Treating those with early COVID-19 disease so that it doesn’t become worse is critical both for the patients and for society,” said George Scangos, Ph.D., Chief Executive Officer, Vir. “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.”

“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,” said Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK. “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.”

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GlaxoSmithKline plc
Vir Biotechnology, Inc.