Preliminary results from a clinical trial of a new drug to treat coronaviruses have shown that its use significantly reduces the number of patients who need artificial lung ventilation, while also cutting the time patients spend in the hospital by one-third.
The treatment, developed by British biotechnology company Synairgen, uses the protein interferon beta, which is produced by the human body to fight viral infections. During treatment, this protein must be inhaled with a special inhaler called a nebulizer. The nebulizer is used to treat bronchial asthma and a number of respiratory diseases by delivering the medication to the lungs in the form of a fine aerosol, which stimulates the body’s immune response.
Preliminary research shows that this treatment reduces by 79% the number of patients in the hospital who develop a severe form of the disease that requires mechanical ventilation of the lungs. Patients have a two to three times greater chance of improving to the point where their disease does not interfere with their daily activities. Interferon beta also reduces the number of patients who suffocate. And the time they spend in the hospital is reduced by a third – from nine to six days.
The double-blind study involved 101 volunteers from nine British hospitals. Half of the participants took a new drug, while the other half took a placebo. None of the study participants knew which treatment had been assigned to which patient until the study was completed. At this time, the results of this study are considered unconfirmed as the Company has not published the results in a peer-reviewed scientific journal. Full data from the study have not yet been published.
However, Tom Wilkinson, the lead researcher, believes that if the results are confirmed, the new drug will change the situation in the treatment of this disease. According to him, although the study itself was small, the results are impressive. Synairgen CEO Richard Marsden called the results a major breakthrough in the inpatient treatment of patients with Covid-19. “The best results, better than this, we couldn’t even hope for,” he added.
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In the coming days, the company will present its findings to health authorities around the world to determine what additional information they need to approve the treatment. This process can normally take months, but the UK government, like many others, has stated that it will work as quickly as possible to approve new developments that promise effective treatment for Covid-19. As a result, the new treatment may be fast-tracked for approval, as was the case with the drug remdesivir in May.
It is also possible that testing on a larger number of patients will be allowed and the results will be carefully studied to confirm safety and efficacy. If the treatment is approved, the drug and nebulizers will need to be manufactured in large quantities.
Richard Marsden has announced that he has given instructions to start production of a new drug as early as April, so that it will be in stock if the positive research results are confirmed. According to him, Synairgen will be able to supply several hundred thousand doses of the drug per month by winter.
Interferon beta is part of the body’s first line of defense against viruses, alerting it to a possible viral attack. The coronavirus apparently suppresses its own production to evade the immune system. The new drug is a special formulation of interferon beta that is delivered directly to the respiratory tract through a nebulizer that converts the protein into an aerosol. The idea is that the dose of protein delivered directly to the lungs will trigger a stronger antiviral response, even in patients whose immune systems have already been weakened by the virus. Interferon beta is commonly used to treat multiple sclerosis.
BBC correspondent Justin Rowlett with nurse Sandy Aitken at the patient’s bed. Previous clinical trials conducted by Synairgen have shown that interferon beta stimulates the immune response and helps patients with asthma and other chronic diseases. The trial of Synairgen’s drug was part of the Accord program, which was established by the UK government to accelerate the development of new drugs for Covid-19 patients.
Developers believe this drug may be even more effective in the early stages of infection. “These results are impossible to interpret. We need the full data and, more importantly, the trial protocol. The trial needs to be registered and the protocol should be available before the analysis is done and conclusions are drawn,” said Professor Steve Goodacre of the University of Sheffield, who specializes in emergency medicine.
Professor Navid Sattar, a specialist in metabolic medicine at the University of Glasgow, said the results were impressive: “Although the study was small, with just over 100 participants, a 79% reduction in the risk of developing severe forms of the disease could have a significant impact. “It would be nice to get to know the full results of the trials once they have been presented and reviewed by experts to ensure that they are reliable and that the trials have been conducted properly. In addition, the fact that the trials were conducted in a small number of patients reduces confidence in the actual benefit of such a treatment. There is no certainty that it will help people in different risk groups. Larger trials need to be done to get this data. But the results are still impressive,” he says.