Synairgen has dosed the first patient in a Phase II trial of inhaled SNG001 for the treatment of patients with chronic obstructive pulmonary disease (COPD).
The SG015 trial is a two-phase study that aims to evaluate the effects of SNG001 in COPD patients.
The first phase of SG015 features dosing ten COPD patients, who have no evidence of viral infection to examine levels of antiviral biomarkers in response to SNG001.
Due to close by next month, the phase seeks to analyse whether administering SNG001 improves antiviral defence mechanisms in the lung in the absence of a respiratory virus.
SG015 trial’s second part is expected to measure various efficacy endpoints and biomarker levels in patients with a respiratory virus.
As part of this phase, 80 patients will be randomised to receive either inhaled SNG001 or placebo.
This part includes the end of the 2017/2018 winter/spring virus season and the 2018 virus season that starts in the autumn.
Synairgen CEO Richard Marsden said: “We have already shown in in-vitro models that SNG001 protects the lung cells of COPD patients when infected with viruses that cause exacerbations such as flu and the common cold.
“However, up until now, our ability to identify those patients who may benefit from an inhaled anti-viral therapy made the design of a prospective study challenging. This has now changed with the development of a point-of-care diagnostic tool, which enables rapid confirmation of the existence of a respiratory viral infection in COPD patients.
“This enables us to treat only those patients who are infected with a virus, significantly reducing the number of subjects required to show the potential effect of SNG001.”
COPD is a progressive lung disease punctuated by periods of exacerbation involving acute worsening of symptoms.