Pharmaceutical giant GlaxoSmithKline (GSK) and Vir Biotechnology have announced the trial of their potential coronavirus treatment will move on to phase three.
The Comet-Ice (Covid-19 monoclonal antibody efficacy trial-intent to care early) study is evaluating Vir-7831 for the early treatment of Covid-19 in patients who are at high risk of being taken to hospital.
Vir-7831 (also known as GSK4182136) is a fully human anti-Sars-CoV-2 monoclonal antibody that was selected based on its ability to neutralise the virus.
It is also thought to kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs.
Following encouraging results from earlier stages of the trial, the study will now expand globally to additional sites in North America, South America and Europe.
George Scangos, chief executive officer of Vir, said: “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.
“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.”
Dr Hal Barron, chief scientific officer and president of research and design at GSK, said: “Given the urgent patient need, I am very pleased that we have progressed Vir-7831 from pre-clinical studies to a phase three trial in only six months since announcing our collaboration with Vir.
“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.”
Initial results may be available as early as the end of 2020, with complete results anticipated in January 2021.
Antibody treatments have recently been in the spotlight after it was announced that US President Donald Trump was given an experimental drug by Regeneron Pharmaceuticals.
Although not yet approved, the company agreed to supply a single dose for Mr Trump at the request of his physician under “compassionate use” provisions.
The new drug is in late-stage testing and its safety and effectiveness are not yet known, and no treatment has yet proven able to prevent serious illness after a coronavirus infection.
Antibodies are proteins the body makes when an infection occurs and vaccines trick the body into thinking there is an infection so it makes these antibodies.
But it can take weeks for them to form after natural infection or a vaccine.