Synairgen PLC (AIM:SNG, OTC:SYGGF) said it is “working in haste” on new trials as it remains encouraged that its lead drug still has potential for patients with severe viral lung infections.
The drug developer reported results for last calendar year showing a loss from operations of £57.9mln compared to £17.7mln, as research and development expenditure increased to £52.9mln from £15.5mln as it carried out Phase 3 trial and manufacturing activities.
At year-end, the cash balance stood at £33.8mln.
Its Phase 3 SPRINTER trial of its SNG001 drug did not meet the primary endpoints, as previously reported, but the company noted follow-on analyses have “indicated stronger treatment effects in high-risk patient sub-groups, with the strongest effect observed in patients with compromised respiratory function despite being on supplemental oxygen”.
These showed a 44% reduction in the intention-to-treat (ITT) population and 70% reduction in the per protocol population, who comprised approximately one-third of the overall trial population.
Chief executive Richard Marsden said: “Since the completion and reporting of the Phase 3 SPRINTER data and subsequent analyses of different high-risk patient groups within the trial, we remain encouraged that SNG001 has the potential to show clinically important benefits in preventing disease progression and death in patients with severe viral lung infections.
“We are now working in haste on discussions with platform trial organisers and investigators, as well as regulatory authorities, the pharmaceutical and biotech industry and government bodies to identify and establish the optimal method of conducting further trials to confirm these findings and move forward.”
Chairman Simon Shaw said the company’s priority is to confirm the signal found from the SPRINTER trial in COVID-19 and to investigate SNG001 in patients hospitalised with viruses such as influenza, respiratory syncytial virus (RSV) and para-influenza.