The first patient has been dosed in a new Phase II/III study assessing the safety and efficacy of an antibody treatment for COVID-19 being developed by GlaxoSmithKline and Vir Biotechnology.
VIR-7831 (also known as GSK4182136), is a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody, designed for early treatment of COVID-19 in patients at high risk of hospitalisation.
The COMET-ICE study, which will enrol around 1,300 patients worldwide who have early symptomatic infection, will assess whether VIR-7831, as a single-dose monoclonal antibody, can prevent hospitalisation due to COVID-19.
Initial read-outs 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 firms noted.
“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,” said George Scangos, Vir's chief executive.
“This study is designed to demonstrate whether VIR-7831 can significantly reduce the need for hospitalisation 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,” noted 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 hospitalised.”
GSK bought a $250-million stake in Vir earlier this year as the companies revealed a collaboration to research and develop solutions for coronaviruses, including COVID-19.