* Phase 2/3 COMET-ICE study will investigate the safety and efficacy of antibody treatment in preventing hospitalisation 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
The aim of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) study, which will enrol approximately 1,300 patients worldwide who have early symptomatic infection, is to assess whether VIR-7831, as a single-dose monoclonal antibody, can prevent hospitalisation 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
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Monoclonal antibodies that neutralise 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 (neutralisation) 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 hypothesised 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 neutralising 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-hospitalised patients. It aims to recruit 20 patients across
The COMET clinical development programme for VIR-7831 also includes two additional planned trials-one for the treatment of severely ill hospitalised 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. About VIR-7831 / GSK4182136
VIR-7831 (GSK4182136) is a monoclonal antibody that has shown the ability to neutralise SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7831/GSK4182136 has been engineered to enhance lung bioavailability and have an extended half-life. About VIR-7832
VIR-7832 is a monoclonal antibody that has shown the ability to neutralise SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7832 has been engineered to enhance lung bioavailability, have an extended half-life, and potentially function as a therapeutic and/or prophylactic T cell vaccine. About the Vir and GSK Collaboration
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Vir Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the potential benefits of Vir's collaboration with GSK, the expected timing of clinical study results for VIR-7831, Vir-7831's potential to treat COVID-19 and its expected clinical activity, clinical trials for VIR-7832, the ability of VIR-7832 to function as a therapeutic and/or prophylactic vaccine and its clinical activity, as well as Vir's ability to identify new anti-viral antibodies and its technologies, as well as Vir's ability to address the current COVID-19 pandemic and future outbreaks of the disease. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials, challenges in identifying new anti-viral antibodies, challenges in neutralizing SARS-CoV-2 or in identifying and inhibiting cellular targets, difficulties in obtaining regulatory approval, challenges in accessing manufacturing capacity, clinical site activation rates or clinical trial enrollment rates that are lower than expected, changes in expected or existing competition, delays in or disruptions to Vir's business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir's filings with the
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