LONDON (ShareCast) - (Sharecast News) - Synairgen announced on Monday that the international phase 3 trial of its SNG001 antiviral inhalation in patients hospitalised with Covid-19 did not meet its primary or key secondary endpoints.
The AIM-traded firm said looking at the primary endpoints, 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 those taking placebo.

It said the evolution in standard-of-care over the course of the pandemic "may have compromised the potential" of SNG001 to show a clinical benefit with regard to the study's primary endpoints, given 87% of patients in phase 3 received systemic corticosteroids for Covid-19 at baseline, whereas none did in the phase 2 study.

Looking at the key secondary endpoints, Synairgen said there was a trend in favour of SNG001 for the measurement of progression to severe disease or death within 35 days, with a 27% and 36% relative risk reduction for the intention-to-treat (ITT) and protocol populations, respectively, in the proportion of patients who were treated with SNG001 compared to patients on placebo.

Synairgen said SNG001 demonstrated a favourable safety profile, and was well-tolerated in the study.

"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," said chief executive officer Richard Marsden.

"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."

The company was now analysing the full dataset to better understand all the findings, Marsden said.

"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."

At 0906 GMT, shares in Synairgen were down 85.1% at 25.48p.

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