A British biotech has announced an inhaled formulation of interferon beta, once licensed by AstraZeneca but later abandoned as an asthma therapy, being tested as a potential treatment for COVID-19, appears to be successful in helping hospitalized patients recover.
The Phase II double-blind placebo-controlled trial called SG016 in hospitalized COVID-19 patients showed positive results, lowering the risk of patients requiring ventilator support.
Synairgen (the respiratory drug discovery and development company that originated from research at the University of Southampton) said the Phase II double-blind placebo-controlled trial called SG016 in hospitalized COVID-19 patients showed positive results, lowering the risk of patients requiring ventilator support.
“Interferon beta (IFN-beta) is a naturally occurring protein, which orchestrates the body’s antiviral responses. There is evidence that deficiency in IFN-beta production by the lung could explain the enhanced susceptibility of these at-risk patient groups to developing severe lung disease during respiratory viral infections,” the company explained.
“Furthermore, viruses, including coronaviruses, have evolved mechanisms which suppress endogenous IFN-beta production, thereby helping the virus evade the innate immune system.
“In the lab IFN-beta has been shown to protect cells from infection with a broad range of respiratory viruses that cause LRT illness including highly pathogenic coronavirus strains, including MERS-CoV (Figure 1 below), SARS-CoV and SARS-CoV-2, the virus which causes COVID-19.”
Synairgen is developing a formulation of IFN-beta, called SNG001, for direct delivery to the lungs via nebulization, to treat and/or prevent LRT illness caused by respiratory viruses.
The key findings from the study included:
- The odds of developing severe disease (e.g. requiring ventilation or resulting in death) during the treatment period (day 1 to day 16) were significantly reduced by 79% for patients receiving SNG001 compared to patients who received placebo (OR 0.21 [95% CI 0.04-0.97]; p=0.046).
- 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 (HR 2.19 [95% CI 1.03-4.69]; p=0.043).
- Over the treatment period, the measure of breathlessness was markedly reduced in patients who received SNG001 compared to those receiving placebo (p=0.007).
- Three subjects (6%) died after being randomised to placebo. There were no deaths among subjects treated with SNG001.
- In the patients with more severe disease at time of admission (i.e. requiring treatment with supplemental oxygen), SNG001 treatment increased the likelihood of hospital discharge during the study, although the difference was not statistically significant (HR 1.72 [95% CI 0.91-3.25]; p=0.096). Median time to discharge was 6 days for patients treated with SNG001 and 9 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 (HR 2.60 [95% CI 0.95-7.07]; p=0.062), although this strong trend did not reach statistical significance. However by day 28, patients receiving SNG001 treatment had statistically significantly better odds of recovery (OR 3.86 [95% CI 1.27-11.75]; p=0.017).
- Interestingly, the efficacy analyses indicate there is no evidence of an association between the SNG001 positive treatment effects and prior duration of COVID-19 symptoms.
Over the treatment period, the measure of breathlessness was markedly reduced in patients who received SNG001 compared to those receiving placebo (p=0.007), the company noted in its release.
“Recognizing 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 neutralize 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,” said Professor Stephen Holgate CBE, Medical Research Council Clinical Professor of Immunopharmacology at the University of Southampton and Co-Founder of Synairgen.
“We are delighted with the positive data produced from this trial, which is the result of a momentous coordinated effort from Synairgen, the University of Southampton, University Hospital Southampton NHS Foundation Trust and the highly expert research teams across the NIHR network and regulatory bodies in the UK,” added Professor Tom Wilkinson, Professor of Respiratory Medicine at the University of Southampton and Trial Chief Investigator.
“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.”