Topline results from phase III SPRINTER trial of SNG 001 a proposed treatment for COVID 19 infection.

SNG 001 demonstrated a favourable safety profile and was well tolerated in this population.

Richard Marsden, CEO of Synairgen, commented: "While we are disappointed by the overall outcome, SNG 001 has been administered to hospitalised patients on top of standard of care which changed substantially between our Phase II and Phase III trials. This improvement in patient care may have compromised the potential of SNG 001 to show a clinical benefit in respect of the endpoints for this study, which were not met. Despite this we have observed an encouraging trend in prevention of progression to severe disease and death, which we strongly believe merits further investigation in a platform trial. We are now analysing the full dataset to better understand all the findings."

"In the meantime, we eagerly await the Phase II data from the US NIH ACTIV-2 trial in home- based COVID-19 patients, and that trial's larger, follow-on Phase III study, as part of the development path for SNG 001."

Efficacy : A total of 623 patients were randomised to receive SNG 001 (n=309) or placebo (n=314) in addition to standard of care (SOC). The primary analysis was conducted in the intention-to-treat population (ITT; all randomised patients). The PP population excludes patients with major protocol violations that may have confounded the results.

Primary Endpoints ;Regarding the primary endpoints , patients who received SNG 001 were no more likely to be discharged from hospital than patients who received placebo, and patients who received SNG 001 were also no more likely to recover to 'no limitation of activities' than patients who received placebo, in both the ITT and PP populations. The evolution in standard of care over the course of the pandemic (for example, 87% of patients in this trial received systemic corticosteroids for COVID-19 at baseline whereas none did in the Phase II study of SNG 001 in COVID-19 may have compromised the potential of SNG 001 to show a clinical benefit in respect of the primary endpoints for this study.