London – The preliminary results of a clinical trial suggest a new treatment for novel coronavirus (COVID-19) dramatically reduces the number of patients needing intensive care, according to the UK company that developed it.
The treatment from Southampton-based biotech Synairgen uses a protein called interferon beta, which the body produces when it gets a viral infection.
The protein is inhaled directly into the lungs of patients with coronavirus, using a nebuliser, in the hope that it will stimulate an immune response.
The initial findings suggest the treatment cut the odds of a COVID-19 patient in hospital developing severe disease – such as requiring ventilation – by 79 per cent.
Patients were two to three times more likely to recover to the point where everyday activities were not compromised by their illness, Synairgen claims.
It said the trial also indicated “very significant” reductions in breathlessness among patients who received the treatment.
In addition, the average time patients spent in hospital is said to have been reduced by a third, for those receiving the new drug – down from an average of nine days to six days.
The double-blind trial involved 101 volunteers who had been admitted for treatment at nine UK hospitals for COVID-19 infections.
Half of the participants were given the drug, the other half got what is known as a placebo – an inactive substance.
Unconfirmed results
Stock market rules mean Synairgen is obliged to report the preliminary results of the trial.
The results have not been published in a peer-reviewed journal, nor has the full data been made available; so the BBC cannot confirm the claims made for the treatment.
But if the results are as the company says, it will be a very important step forward in the treatment of coronavirus infections.
The scientist in charge of the trial, Tom Wilkinson, says if the results are confirmed in larger studies the new treatment will be “a game changer”.
The trial was relatively small but the signal that the treatment benefits patients was unusually strong, he says.
“We couldn’t have expected much better results than these,” Synairgen chief executive Richard Marsden told the BBC.
He described the results as “a major breakthrough in the treatment of hospitalised COVID-19 patients”.
What happens next?
Marsden said the company will be presenting its findings to medical regulators around the world in the next couple of days to see what further information they require in order to approve the treatment.
That process could take months, although the British government, like many others, has said it will work as fast as possible to get promising coronavirus treatments approved.
It is possible it could be given emergency approval, as the anti-viral drug remdesivir was in May.
Another possibility is that permission will be given for more patients to receive the treatment with the effects being carefully monitored to confirm it is safe and effective.
If it does get approval, the drug and the nebulisers used to deliver it would then need to be manufactured in large quantities.
Marsden says he instructed companies to start producing supplies back in April to ensure they would be available should the results be positive.
He says he expects Synairgen to be able to deliver “a few 100 000” doses a month by the winter. (BBC)
