Southampton, UK-based Synairgen has announced positive results from a clinical trial of SNG001, its wholly-owned inhaled formulation of interferon beta, in hospitalised COVID-19 patients.
The risk of developing severe disease (requiring ventilation or resulting in death) during the treatment period (day one to day 16) was significantly cut by 79% for patients receiving SNG001 compared to patients who received placebo.
Data also showed that patients who received SNG001 were more than twice as likely to recover (defined as ‘no limitation of activities’ or ‘no clinical or virological evidence of infection’) over the course of the treatment period compared to those receiving placebo, while the measure of breathlessness was “markedly reduced” in patients who received the drug compared to those in the control arm.
Also of note, in patients with more severe disease at time of admission, SNG001 treatment increased the likelihood of hospital discharge during the study, although the difference was not statistically significant, at six days versus nine days for those receiving placebo.
Furthermore, patients receiving SNG001 appeared to be more than twice as likely to have recovered by the end of the treatment period, 'although this strong trend did not reach statistical significance,' the firm said. However, by day 28, patients receiving SNG001 had statistically significantly better odds of recovery.
On the safety side, it was noted that three subjects (6%) died after being randomised to placebo, but there were no deaths among those given SNG001.
"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,” Professor Tom Wilkinson, Professor of Respiratory Medicine at the University of Southampton and trial chief investigator.
“Recognising that SARS-CoV-2 is known to have evolved to evade the initial antiviral response of the lung, our inhaled treatment of giving high local concentrations of interferon beta, a naturally occurring antiviral protein, restores the lung’s ability to neutralise the virus, or any mutation of the virus or co-infection with another respiratory virus such as influenza or RSV, as could be encountered in the winter if there is a resurgence of COVID-19,” added Professor Stephen Holgate CBE, Medical Research Council Clinical Professor of Immunopharmacology at the University of Southampton and Co-Founder of Synairgen.