GSK, Vir Biotechnology Expand Phase 3 Study of COVID-19 Antibody
The global expansion of the study will reach sites in North America, South America, and Europe to evaluate the COVID-19 antibody treatment in patients who are at high risk of hospitalization.
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By - Vir Biotechnology and GSK recently announced the global expansion of a Phase 3 study evaluating their COVID-19 antibody, VIR-7831.
The COMET-ICE study will evaluate VIR-7831 in patients who are at high risk of hospitalization from the coronavirus.
The antibody was selected based on study data that showed the antibody can neutralize the virus, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs, a GSK spokesperson explained.
The global expansion will reach sites in North America, South America, and Europe.
“Given the urgent patient need I am very pleased that we have progressed VIR-7831 from pre-clinical studies to a Phase 3 trial in only six months since announcing our collaboration with Vir,” Hal Barron, PhD, chief scientific officer and president of research and development at GSK, said in the announcement.
“We believe this neutralising antibody’s high barrier to resistance, notable effector function, and enhanced delivery into the lung suggest it has best-in-class potential in the fight against this global pandemic.”
At the beginning of September, GSK and Vir dosed the first patients in a Phase 2/3 study evaluating VIR-7831.
The lead-in phase of COMET-ICE enrolled 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 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.
The Phase 3 portion of COMET-ICE will further uncover the safety and efficacy of a single intravenous infusion of VIR-7831 or placebo in 1,300 non-hospitalized participants.
The endpoint will be the number of patients who see a progression of COVID-19, which will be determined by the need for hospitalization or death within 29 days of randomization, GSK said.
The full results of the study may be available by the end of 2020 and results for the primary endpoint are expected in early 2021.
“The rapid achievement of this important milestone reflects the urgency with which we’re mobilising our resources in the hope of preventing the worst consequences of this deadly virus,” said George Scangos, PhD, chief executive officer of Vir.
“VIR-7831 is an antibody with characteristics that may enable it to prevent hospitalisation or death via multiple mechanisms. We look forward to continuing to collaborate with GSK to accelerate its development.”
The companies noted that later this year they will start a Phase 1b/2a trial of their other investigational COVID-19 antibody, VIR-7832. This is similar to VIR-7831 but may also function as a therapeutic or prophylactic T-cell vaccine.
The recent announcement comes six months after GSK and Vir announced a collaboration to enhance COVID-19 drug discovery through the use of CRISPR and artificial intelligence.
CRISPR is a gene-editing tool to edit human genes, also known as in vivo gene editing. Access to genetic material in the body is vital to boost potential vaccine development.
CRISPR screening allows for researchers to identify targets that may prevent viral infection. Previously, Vir 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.”
