Synairgen plc the respiratory drug discovery and development company, has announced that the first patient has been dosed in the UK as part of its global Phase III trial (SG018) evaluating Synairgen’s inhaled formulation of interferon beta-1a (SNG001), for the treatment of hospitalised COVID-19 patients.
Synairgen’s SG018 trial is a randomised placebo-controlled study being conducted in approximately 20 countries enrolling a total of 610 COVID-19 patients who require supplemental oxygen. After reporting the results for the primary and key secondary endpoints of the study, enrolled patients will continue to be assessed for long-COVID-19 symptoms.
The first trials of the inhaled drug for use in preventing the worsening of COVID-19 in those most at risk opened in Southampton and 10 other NHS hospitals last March involving 100 patients. Those trials were led by Tom Wilkinson, Professor of Respiratory Medicine in the University’s Faculty of Medicine and a consultant in respiratory medicine at University Hospital Southampton who said, “If we had a positive study, we would hope to move rapidly into scaled manufacture and delivery of the drug in clinical practice.”
He added that he believes the new drug would be a complement to the vaccines rolling out and emphasised the need for other treatments as vaccinating the world takes time and there is a risk of the virus mutating making vaccines less effective.
In May, Phase II of the Southampton trial began to roll out beyond Southampton with people who had tested positive for COVID-19 given the drug in their homes. This was widened further in June to encompass people aged 50 and over, and 65 and over, with a high-risk comorbidity (such as cardiovascular disease, diabetes or a chronic lung conditions). Patients involved also needed to have had symptoms for less than four days.
Synairgen, the drug development company, was founded by University of Southampton Professors Stephen Holgate, Donna Davies and Ratko Djukanovic. The company developed SNG001 to prevent severe lower respiratory tract illness caused by cold and flu infections when they spread to the lungs.
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 interferon beta, a natural antiviral produced in all our lungs during viral lung infections. SNG001 delivers extra interferon beta direct to the lungs, correcting this deficiency and counteracting viral strategies to evade the host’s immune defences by inhibiting natural interferon beta production.
As previously announced, Synairgen has appointed Parexel Biotech, a division of the leading global clinical research organisation, Parexel, to help conduct the Phase III trial and several UK sites have now been initiated, with further sites in the US and the EU expected to follow.
The trial is deemed an Urgent Public Health study by the UK’s National Institute for Health Research (NIHR). In the US, SNG001 has been granted Fast Track status from the US Food and Drug Administration (FDA). The Company is seeking further equivalent prioritisations and support from governments in participating countries.
Richard Marsden, CEO of Synairgen, commented: “We need treatments as well as vaccines to fight highly pathogenic viruses such as SARS-CoV-2. Development of treatments like ours will remain necessary in cases where vaccines are not effective, for those who do not get vaccinated, and in case the virus mutates to the point where vaccines become less effective. We believe this trial presents an opportunity for a significant UK scientific breakthrough and, if given the right support, our drug could rapidly assist with the global crisis.”