Topline results from Phase 3 SPRINTER trial
Synairgen plc (LSE: SNG), the respiratory company developing SNG001, a formulation for inhalation containing the broad-spectrum antiviral protein interferon beta, today announces that the international Phase 3 SPRINTER trial of SNG001 in patients hospitalised with COVID-19 did not meet its primary or key secondary efficacy endpoints. SNG001 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, SNG001 has been administered to hospitalised patients on top of standard of care which changed substantially between our Phase 2 and Phase 3 trials. This improvement in patient care may have compromised the potential of SNG001 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 2 data from the US NIH ACTIV-2 trial in home- based COVID-19 patients, and that trial`s larger, follow-on Phase 3 study, as part of the development path for SNG001."
Efficacy
A total of 623 patients were randomised to receive SNG001 (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). Data for the per protocol population (PP) is also shown. The PP population excludes patients with major protocol violations that may have confounded the results.
Primary Endpoints
Regarding the primary endpoints (Table 1), patients who received SNG001 were no more likely to be discharged from hospital than patients who received placebo, and patients who received SNG001 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 2 study of SNG001 in COVID-19[1]) may have compromised the potential of SNG001 to show a clinical benefit in respect of the primary endpoints for this study.