The trial evaluated the safety of the drug in COPD patients and its clinical benefit in participants when they have a cold or flu infection, which is a major cause of COPD exacerbations.
In the first part of the SG015 trial, 10 COPD patients with no evidence of viral infection were dosed with SNG001.
The objective of this part of the trial was to evaluate safety and if administering the drug improves antiviral defence mechanisms in the lung in the absence of a respiratory virus, by means of biomarker analysis.
Synairgen said that the safety data from the first part was reviewed by the Drug Safety Monitoring Committee which has given its nod to go ahead with the second part of the SG015 trial.
Slated to cover the 2018/19 winter cold virus season, the second part of the study is designed to record multiple efficacy endpoints and biomarker levels in patients suffering from a respiratory virus.
Synairgen is looking to have 80 patients with confirmed respiratory viruses. The patients will be randomly divided to be subjected with either inhaled SNG001 or placebo.
Synairgen CEO Richard Marsden said: “COPD is a very severe disease and it is reassuring to establish that SNG001 is well tolerated in these patients. 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.”
According to Synairgen, SNG001 is an inhaled interferon beta (IFN-beta) therapeutic candidate. The company said that the drug can 'orchestrate' antiviral defence mechanisms to protect COPD lung cells from cold and flu viruses in in vitro models.
In mid-2014, AstraZeneca purchased the global licensing rights from Synairgen for SNG001 in a deal worth up to $225m.
Image: Synairgen’s respiratory drug SNG001 is being evaluated in a phase 2 COPD trial. Photo: courtesy of jk1991/FreeDigitalPhotos.net.