A potential new coronavirus antibody treatment made by a British pharmaceutical giant has moved into late stage trials.
Brentford-based GlaxoSmithKline (GSK) said its treatment – known as Vir-7831 – could be rolled out by 2021 if its proven to be effective and safe.
The drug uses antibodies – proteins found in people who have survived Covid-19 – that have been genetically modified in a lab. These substances are then injected into patients in the earliest stages of their illness.
This is significant because, currently, there are no drugs on the market that prevent people from falling severely unwell with the disease.
The only medicines scientifically proven to have an effect are steroids that for people already on ventilators or with dangerously low oxygen levels.
An early trial on 20 patients in the US suggested the new antibody medicine was safe and did not cause any adverse health effects.
Now the study will expand across North America, South America and Europe and aim to recruit nearly 1,500 volunteers to see if the drug can prevent serious illness.
Brentford-based GlaxoSmithKline (GSK) said its treatment – known as Vir-7831 – could be rolled out by 2021 if its proven to be effective and safe
Antibodies are proteins the immune system makes when someone becomes infected with a virus, such as the pathogen that causes Covid-19.
But it can take weeks for them to form after being infected or having a vaccine, which is often too late as the virus has already multiplied in the body.
For some people – particularly the elderly and those with weakened immune systems – their bodies struggle to muster up enough antibodies to fight the disease.
GSK’s treatment uses monoclonal antibodies – which have been engineered in a laboratory and mimic antibodies naturally produced by recovered Covid patients.
If GSK’s therapy works it could be a way to equip people’s immune systems to fight the coronavirus before their condition deteriorates.
Monoclonal antibodies are already being used to treat tetanus, Ebola and diphtheria.
The therapy has recently been in the spotlight after it was announced that US President Donald Trump was given an experimental cocktail of the proteins following his Covid-19 diagnosis.
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.
GSK and San Francisco-based Vir Biotechnology have been working on their treatment since April after joining forces when the pandemic first took off.
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.’
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.’
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 with early stages of the disease.
It aims to recruit 1,300 participants, half of whom will receive the drug while the others are given a placebo.
GlaxoSmithKline also has a vaccine candidate in human trials, which the UK Government has already struck a multi-million pound deal for 60million doses of.
The Department for Business, Energy and Industrial Strategy penned the deal with GSK and Sanofi Pasteur, who has co-created the jab, on July 29.
The 60million doses are rumoured to have cost £500million, but Britain will only pay if it turns out to work and be effective.
Human trials began this month and the drugmakers hope to follow them up with phase 3 studies by December.