Hospitalized COVID-19 patients treated with the investigational therapeutic SNG001 were 79% less likely to develop severe disease and more than twice as likely to recover compared to control group, according to preliminary findings released by manufacturer Synairgen.
SNG001 is an inhaled formulation of interferon beta, (IFN-beta-1a), which is delivered directly to the lungs via nebulization, Synairgen reports. It is pH neutral, and is free of mannitol, arginine and human serum albumin, making it suitable for inhaled delivery direct to the site of action.
Synairgen’s double-blind placebo-controlled trial recruited 101 patients from 9 specialist hospital sites in the UK during the period 30 March to 27 May 2020. Patient groups were evenly matched in terms of average age, comorbidities, and average duration of COVID-19 symptoms prior to enrollment.
According to results, 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).
Additionally, 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 randomized to placebo. There were no deaths among subjects treated with SNG001.
In the patients with more severe disease at time of admission (ie 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).
“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,'” said Richard Marsden, CEO of Synairgen. “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.”