Vir Biotechnology and GlaxoSmithKline (GSK) have started a phase 2/3 study of VIR-7831 (also known as GSK4182136) as a Covid-19 antibody treatment by dosing the first patient.
VIR-7831 is a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody that is being developed for the early treatment of the viral disease in patients who are at high risk of hospitalisation.
The COMET-ICE study which expands to Covid-19 monoclonal antibody efficacy trial – intent to care early will have nearly 1,300 patients across the world who have early symptomatic infection.
According to GSK, the mid-stage trial will assess if VIR-7831 given as a single-dose monoclonal antibody can help patients avoid hospitalisation due to Covid-19.
Vir Biotechnology CEO George Scangos 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 hospitalisation in high-risk individuals, such as the elderly or those with pre-existing conditions such as lung or heart disease.”
Initial results from the COMET-ICE trial are expected to be released by the end of this year, with full results likely to come out in the first quarter of 2021. GSK said that the early access to the antibody treatment could potentially be in the first half of 2021.
The phase 2/3 trial of VIR-7831 follows the collaboration deal signed by Vir Biotechnology and GSK in April 2020, aimed at jointly researching and developing solutions for SARS-CoV-2 and other coronaviruses.
The COMET-ICE trial will be made up of two parts with the first one being the lead-In phase, which will serve as the first-in-human assessment of the drug candidate. The lead-in phase will evaluate VIR-7831’s safety and tolerability for its single 500mg intravenous (IV) infusion over a 14-day period in 20 non-hospitalised patients across the US.
After the initial safety assessment, the second part, which is the expansion phase, will begin with the objective of reducing the necessity for hospitalisation. It will evaluate the drug candidate’s safety and efficacy for its single IV infusion in nearly 1,300 non-hospitalised participants across the world.
The primary efficacy endpoint of the mid-stage trial will be the proportion of patients with mild or moderate Covid-19 whose condition worsens leading to the need for hospitalisation or death, within 29 days of randomisation.
GSK chief scientific officer and R&D president Hal Barron 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.”