Southampton researchers are trialling an inhaled drug that could prevent worsening of COVID-19 in those most at risk.
The trial, led by Tom Wilkinson, professor of respiratory medicine at the University of Southampton and a consultant in respiratory medicine at University Hospital Southampton, will involve 100 patients at Southampton and up to 10 other NHS hospitals taking part.
Those patients will receive the best current COVID-19 care, whilst inhaling either a placebo or SNG001, a special formulation of the naturally occurring antiviral protein interferon beta 1a (IFN-β), for 14 days.
SNG001 has been developed by Synairgen – a drug development company founded by University of Southampton professors Stephen Holgate, Donna Davies and Ratko Djukanovic – to prevent severe lower respiratory tract illness caused by cold and flu infections when they spread to the lungs.
Phase II clinical trials in asthmatic patients have previously shown that SNG001 is well tolerated, enhances the lungs’ antiviral defences and improves lung function during cold or flu infection.
Southampton researchers have shown that key high risk groups for COVID-19, including older people and those with some chronic diseases have lower levels of IFN-β, a natural antiviral produced in all our lungs during viral lung infections.
SNG001 delivers extra IFN-β direct to the lungs, correcting this deficiency and counteracting viral strategies to evade the host’s immune defences by inhibiting natural IFN-β production.
Professor Wilkinson said: “COVID-19 is presenting a major challenge to vulnerable patients, the health service and wider society whilst a vaccine will be key, that could be some time away. Right now we need effective frontline treatments to give doctors the tools to treat the most vulnerable and to help patients recover quickly as the pressure on health systems mounts.”
Responding to the urgency of the pandemic, Synairgen and Professor Wilkinson worked with regulators and Southampton’s R&D department to open the study within weeks.
“We have worked intensively with the relevant authorities and collaborators to enable SNG001 to be assessed in COVID-19 patients. A successful outcome from this trial in COVID-19 patients would be a major breakthrough in the fight against this coronavirus pandemic,” said Richard Marsden, CEO of Synairgen.
Study measures will include World Health Organisation recommended assessments of illness severity, and treatment intensity measures alongside standard assessments of safety.
Positive initial results from the 100 patient pilot phase could see the trial expanded to more hospitals, with Synairgen increasing production of the drug in parallel.
“Having the trial adopted by the NIHR Respiratory Translational Research Collaboration, is key to taking any positive findings forward as part of their efforts to accelerate discovery and development for COVID-19 and I am indebted to the support my collaborators are giving to get this study started,” Professor Wilkinson added.