Researchers are investigating whether the inhaled interferon beta treatment can better protect sufferers of chronic obstructive pulmonary disease (COPD) from the exacerbating effects of illnesses such as flu and the common cold.
Part two gets thumbs-up
The mid-stage trial, called SG015, is taking place in two parts. The initial stage involves dosing ten people who have no evidence of viral infection to examine levels of antiviral biomarkers in response to the drug.
The aim is to assess whether SNG001 boosts antiviral defence mechanisms in the lung in the absence of a respiratory virus. Completion of the first stage is expected by the end of March.
Phase-two is designed to measure what Synairgen describes as “efficacy endpoints” and biomarker levels in patients with a respiratory virus.
A total of 80 patients will take part, receiving either SNG001 or a placebo that has no medical impact on the person receiving it.
As a result of Friday’s positive safety data, the Drug Safety Monitoring Committee has given Synairgen the thumbs-up to go ahead with the second part of the trial, which is scheduled to cover the 2018/19 winter cold virus season.
'Reassuring' safety data
“COPD is a very severe disease and it is reassuring to establish that SNG001 is well tolerated in these patients,” said Synairgen chief executive Richard Marsden.
“We look forward to seeing the biomarker analysis, which is due in the near term to see whether SNG001 has switched on the antiviral defence mechanisms.
“Changes in biomarkers translated into clinical benefit in Phase II trials in asthma. Therefore, if we see similar biomarker changes in this study, it will greatly increase our confidence in the potential of SNG001 in COPD, where colds and flu can cause more severe symptoms than in asthma.”