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 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 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
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-center, 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 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 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 neutralize 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.
VIR-7832 is a monoclonal antibody that has shown the ability to neutralize 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
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.
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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GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK’s “Principal risks and uncertainties” section of the Q2 Results and any impacts of the COVID-19 pandemic.
Vir Biotechnology Contacts: Investors
Neera Ravindran, M.D. VP, Head of Investor Relations & Strategic Communicationsnravindran@vir.bio +1 415 506 5256 GSK Contacts: Media Julie NormartW2O email@example.com +1 559 974 3245 Media: Simon Steel+44 (0) 20 8047 5502 ( London) Tim Foley+44 (0) 20 8047 5502 ( London) Kristen Neese+1 804 217 8147 ( Philadelphia) Kathleen Quinn+1 202 603 5003 ( Washington DC) Analysts/Investors: Sarah Elton-Farr+44 (0) 20 8047 5194 ( London) Sonya Ghobrial+44 (0) 7392 784784 (Consumer) Danielle Smith+44 (0) 20 8047 0932 ( London) James Dodwell+44 (0) 20 8047 2406 ( London) Jeff McLaughlin+1 215 751 7002 ( Philadelphia) Frannie DeFranco+1 215 751 4855 ( Philadelphia)
Source: Vir Biotechnology, Inc.