GSK, Vir Dose First Patient in Phase 2/3 COVID-19 Antibody Study

September 02, 2020 - GlaxoSmithKline (GSK) and Vir Biotechnology recently announced that the first patient was dosed in a Phase 2/3 study evaluating the safety and efficiency of a COVID-19 antibody treatment.

The antibody, VIR-7831, is intended to be used for the early treatment of COVID-19 in patients who are at high risk of hospitalization. 

The study, COMET-ICE, will enroll nearly 1,300 patients worldwide who have symptomatic infection to uncover if one single-dose of the monoclonal antibody can prevent hospitalization due to COVID-19.

The initial results will be available before the end of 2020, the companies stated, with complete results of the study and early access to the antibody treatment expected at the beginning of 2021.

 “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,” Hal Barron, MD, chief scientific officer and president of R&D at GSK, said in the announcement.  

“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.”

The lead-in phase of COMET-ICE will enroll 20 patients to assess the safety and tolerability of a single 500 milligram intravenous infusion of VIR-7831 or a placebo over a period of 14 days in hospitalized patients.

The expansion phase will assess the safety and efficacy of a single IV infusion of VIR-7831 or placebo in an effort to reduce the need for hospitalization.

GSK stated that the primary endpoint of the study is the proportion of patients with mild or moderate COVID-19 who worsen, which means hospitalization or death, within 29 days of randomization. 

COMET ICE clinical development program for the monoclonal antibody also includes two additional planned trials for the treatment of severely ill hospitalized patients and for the prophylaxis of symptomatic infection. 

Later this year, the companies will start a Phase 2 trial of their other investigational COVID-19 antibody, VIR-7832, the companies stated. This is similar to VIR-7831 but may also function as a therapeutic 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. Hospital systems are overwhelmed worldwide, with new infections continuing to strain already limited resources,” said George Scangos, PhD, chief executive officer of Vir.

“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.” 

This announcement of the first patient dosed in a Phase 2/3 study comes five months after GSK and Vir collaborated to enhance COVID-19 drug discovery through the use of CRISPR and artificial intelligence. 

The partnership aimed to accelerate the development of specific antibody candidates using Vir’s monoclonal antibody platform technology and GSK’s expertise in functional genomics. 

The companies used CRISPR screening and artificial intelligence to uncover anti-coronavirus compounds that target host genes. 

CRISPR is a gene-editing tool to edit human genes, also known as in vivo gene editing. With the current COVID-19 pandemic, access to genetic material in the body is vital to boost potential drug and vaccine treatment.

CRISPR screening allows for researchers to identify targets that may prevent viral infection. Previously, Vir has identified various potential treatments against the flu and other respiratory pathogens, as well as hepatitis B virus.

“It is becoming increasingly clear that multiple therapeutic approaches, used in combination or in sequence, will be necessary to stop this coronavirus pandemic. It is likely that the current coronavirus outbreak will not be the last,” George Scangos, PhD, CEO of Vir Biotechnology, said in the April announcement. 

“These insights are informing our scientific approach and we are pleased to join forces on the execution of this strategy with GSK, who have a like-minded R&D strategy, a deep expertise in vaccines and an impressive global reach to bring medicines to people around the world.”