Synairgen PLC (AIM:SNG, OTC:SYGGF) said its treatment for Covid failed to meet both its primary and secondary goals in a phase III clinical trial.
SNG001 did not materially shorten hospital stay or recovery time compared with the standard of care, investors were told.
However, as Richard Marsden, Synairgen’s chief executive pointed out, this may be the result of significant changes in the way patients are routinely treated in the period between the phase II and phase III evaluations.
“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,” he explained.
“Despite this, we have observed an encouraging trend in the 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."
A total of 623 people hospitalised with the virus took part in the SPRINTER study of the inhaled interferon beta treatment.
It was found to have a ‘favourable’ safety profile, and as mentioned in Marsden’s quote there was a “trend in favour of SNG001 for the endpoint measuring progression to severe disease or death”.
Tom Wilkinson, the trial’s chief investigator, noted: “Better treatments for severe disease are still desperately needed but what's clear is that improvements in outcomes-driven by vaccination and the evolution in standards of care mean that larger studies are required to definitively explore SNG001's impact on mortality and severe disease.
“With the strong safety profile that this treatment now has shown, it is appropriate for it to be considered by the large platform studies to confirm efficacy signals in severe COVID-19."
SNG001 is currently being assessed for possible use in Covid patients at home as part of the US National Institute of Health's ACTIV-2 trial.
Last October the inhaled drug was green-lit to advance from phase II to phase III in mild to moderate virus sufferers.