Inhaled Interferon Beta Formulation Decreases Severity Risk by 79% in COVID-19 Patients

Synairgen conducted a Phase 2 double-blind placebo-controlled trial involving 101 patients from nine specialist hospital sites during the period 30 March to 27 May 2020. The patient groups were evenly matched in terms of average age (56.5 years for placebo and 57.8 years for SNG001), comorbidities and average duration of COVID-19 symptoms prior to enrolment (9.8 days for placebo and 9.6 days for SNG001).

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. 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. Over the treatment period, the measure of breathlessness was markedly reduced in patients who received SNG001 compared to those receiving placebo. Three subjects (6%) died after being randomized to placebo, while there were no deaths among subjects treated with SNG001.

In 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. Median time to discharge was six days for patients treated with SNG001 and 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. However, by day 28, patients receiving SNG001 treatment had statistically significantly better odds of recovery. 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.

“We are all delighted with the trial results announced today, which showed that SNG001 greatly reduced the number of hospitalized COVID-19 patients who progressed from ‘requiring oxygen’ to ‘requiring ventilation’. It also showed that patients who received SNG001 were at least twice as likely to recover to the point where their everyday activities were not compromised through having been infected by SARS-CoV-2,” said Richard Marsden, CEO of Synairgen. “In addition, SNG001 has significantly reduced breathlessness, one of the main symptoms of severe COVID-19. This assessment of SNG001 in COVID-19 patients could signal a major breakthrough in the treatment of hospitalized COVID-19 patients. 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.”

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