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Monday, 20 July 2020

New coronavirus drug shows positive results in first trial

New coronavirus drug shows positive results in first trial

* Patients were 79 per cent less likely to need ventilation

A British drug has been found to dramatically reduce the chances of coronavirus patients needing intensive care, according to the preliminary results of a small randomised trial.

Hospitalised patients who inhaled a protein designed to stimulate the immune system were 79 per cent less likely to deteriorate to the point where they needed ventilation.

However, other researchers said that larger trials were needed to be sure of its findings, with a lot of uncertainty about the strength of its effect.

The trial of the drug, developed at the University of Southampton, involved 101 patients, half of whom received a placebo. The data will need to be closely examined by other scientists and has not yet been released for peer review.

Synairgen, the pharmaceutical company developing the drug, is obliged by stock market rules to report preliminary results. If confirmed the findings would represent a dramatic breakthrough, adding to the small stock of drugs able to change the course of the disease.

It had struck a struck a deal worth up to $232 million in 2014 with Astrazeneca to give the FTSE 100 company rights to the drug as an experimental treatment for viral infections in severe asthmatics.

A trial was stopped in October 2016 after Synairgen said cold infections did not affect asthma in the study as much as predicted, but said it did switch on the lung’s antiviral defences and had a beneficial effect on lung function.

Nonetheless, in 2017 Astrazeneca decided to discontinue development of the drug licensed from Synairgen, which triggered a slump in Synairgen’s share price.

Until now only remdesivir, an anti-viral, and dexamethasone, a steroid, have been shown to have a clinical effect.

The effectiveness of remdesivir was relatively low, merely lessening the time people spent in hospital, while dexamethasone was only useful in a subset of patients.

The patients involved in the Southampton trial were more than twice as likely to recover to the point where they could return to normal life. Of those in the placebo group, three died while all in the treatment arm survived.

However, because of the size of the study compared with those that showed the efficacy of remdesivir and dexamethasone, researchers were wary of putting too much confidence in it.

The drug contains a protein called interferon beta which the immune system uses to signal to the body and muster a response.

One of the tricks of the coronavirus is believed to be that it suppresses this response, which was what led the researchers to initially turn to it in trials.

By inhaling the protein in an aerosol, the scientists believe it restores the lung’s ability to naturally neutralise the virus.

“The results confirm our belief that interferon beta, a widely known drug that, by injection, has been approved for use in a number of other indications, has huge potential as an inhaled drug to be able to restore the lung’s immune response, enhancing protection, accelerating recovery and countering the impact of SARS-CoV-2 virus,” Tom Wilkinson, professor of respiratory medicine at the University of Southampton, said.

Daniel Davis, professor of immunology at Manchester University and the author of The Beautiful Cure, a book about the immune system, said he was excited by the findings.

“If confirmed, use of interferon beta for treating Covid-19 is wonderful news. By giving an inhaled interferon, the lung’s natural immune defence could be given the boost it needs to fight off the infection.

More research is needed to establish appropriate dosing and timing, and interferons can have side-effects which need to be scrutinised here.

This is now the third drug which holds real promise for treating patients, and it is genuinely thrilling to see progress happening so fast.”

Regulators typically take months to bring a drug from this stage to market but if the promising early findings are confirmed it is expected to be fast-tracked. It will still require a far larger trial, either during a second wave in the UK, or abroad.

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Martin Landray, from the University of Oxford, is one of the scientists running the Recovery Trial, the UK’s flagship trial of coronavirus treatments.

He said the latest results were very promising, but should be treated with caution. “This is a small study, in an early phase. It is better to see encouraging results than negative results, but one shouldn’t get over-excited.”

Although the headline figure was a 79 per cent reduction in those going to intensive care, with 50 patients in the treatment group, the uncertainty in that number was high, he said.

“We’re all so desperate for good treatments, it’s easy to jump on any good news and say we have found a cure,” Professor Landray said. “We have not found a cure.

These are the sort of results that encourage scientists to go from a 100-patient study to 1,000 patients and find out the real value.”

Naveed Sattar, professor of metabolic medicine at the University of Glasgow, agreed that a bigger study was needed, although he added that even so the drug could be a “game-changer”.

“It would be good to see the full results once presented and peer-reviewed to make sure they are robust and the trial conduct was rigorous,” he said.

“Also, with small numbers comes less certainty on the true level of benefit, or whether benefits vary between people with differing risk characteristics.”

Source .  The Times

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