Inhaled interferon beta shows promise for severe COVID-19

Inhaled interferon beta lowered the risk for developing severe infection and improved the likelihood of recovery from COVID-19 compared with placebo, according to early data released by Synairgen.

The company released early results from its double-blind, placebo-controlled trial, which enrolled 101 patients with COVID-19 at nine sites in the United Kingdom from March 30 to May 27. Patients in the hospital setting were randomly assigned to treatment with inhaled interferon beta (SNG001, Synairgen) or placebo. Patient groups were evenly matched, with a mean age of about 57 years and COVID-19 symptoms prior to enrollment for about 9 days.

The positive findings were released in a press release by the company and have not yet been published.

According to the early results, the odds of developing severe COVID-19 infection requiring ventilation or resulting in death during the treatment period, from day 1 to day 16, was reduced by 79% for patients receiving inhaled interferon beta compared with placebo (OR = 0.21; 95% CI, 0.04-0.97; P = .046). Patients receiving inhaled interferon beta were more than twice as likely to recover from COVID-19 infection during the treatment period compared with the placebo group (HR = 2.19; 95% CI, 1.03-4.69; P = .043), according to the release. Further, patients receiving inhaled interferon beta appeared to be more than twice as likely to have recovered by the end of the treatment period (HR = 2.6; 95% CI, 0.95-7.07; P = .062). By day 28, patients receiving inhaled interferon beta had significantly better odds of recovery (OR = 3.86; 95% CI, 1.27-11.75; P = .017), according to the release.

In addition, breathlessness was significantly reduced in the inhaled interferon beta group compared with placebo (P = .007). During the treatment period, there were no deaths among patients assigned inhaled interferon beta and three patients (6%) in the placebo group died, according to the release.

Among patients with more severe disease at the time of admission, including those requiring supplemental oxygen, inhaled interferon beta increased the likelihood of discharge during the study (HR = 1.72; 95% CI, 0.91-3.25; P = .096). Median time to discharge was 6 days in the inhaled interferon beta group compared with 9 days in the placebo group, according to the release.

“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,” Tom Wilkinson, MA Cantab, MBBS, PhD, FRCP, professor of respiratory medicine at the University of Southampton and trial chief investigator, stated in the release.

Interferon beta is a naturally occurring protein that orchestrates the body’s antiviral responses. SNG001 is a formulation of IFN-beta-1a for direct delivery to the lungs via nebulization. Previous phase 2 clinical trials in asthma showed that inhaled SNG001 treatment activated antiviral pathways in the lung and improved lung function in patients with a respiratory viral infection, according to information from the company.

The trial of SNG001 in patients hospitalized with COVID-19 is a phase 2 trial. The trial researchers will also evaluate outcomes among patients to be initiated in the home setting, according to the release.

“This assessment of SNG001 in COVID-19 patients could signal a major breakthrough in

the treatment of hospitalized COVID-19 patients,” Richard Marsden, CEO of Synairgen, stated in the release. “Our efforts are now focused on working with the regulators and other key groups to progress this potential COVID-19 treatment as rapidly as possible."

Further analysis on SNG001 to treat patients with COVID-19 will be conducted in late 2020, according to the company.