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Synairgen doses first patients in SNG001 trial
Respiratory drug discovery and development company Synairgen announced on Wednesday that the first patients have been dosed in the company's Phase II trial of inhaled SNG001 in patients with chronic obstructive pulmonary disease (COPD).
The AIM-traded firm described COPD as a progressive lung disease, punctuated by periods of exacerbation involving acute worsening of symptoms, which had major implications for both the patient and the healthcare system.
COPD exacerbations were said to be the second most common cause of hospitalisation.
The risk that a cold would cause an exacerbation of COPD was around 50%, and could be even higher in certain at-risk patients.
SNG001, which is wholly-owned by Synairgen, is an inhaled interferon beta therapeutic candidate which had been shown to "orchestrate" antiviral defence mechanisms to protect COPD lung cells against a range of common viruses in in vitro models.
Synairgen's two-part Phase II trial, called SG015, was designed to assess the effects of SNG001 in COPD patients, the board explained.
The first part of the SG015 trial would involve dosing 10 COPD patients who had no evidence of viral infection, to examine levels of antiviral biomarkers in response to SNG001.
Synairgen said the aim was to assess whether administering SNG001 boosted antiviral defence mechanisms in the lung, in the absence of a respiratory virus.
The first part of the trial was scheduled to complete in the first quarter of 2018.
Synairgen said the second part of the SG015 trial was designed to measure various efficacy endpoints and biomarker levels in patients with a respiratory virus.
In that part, 80 patients would be randomised to receive either inhaled SNG001 or placebo.
That part of the trial would bridge the end of the 2017/2018 winter/spring virus season and the 2018 virus season which starts in the autumn.
"We are excited to begin evaluating SNG001 in COPD, where exacerbations are a significant health risk and economic burden," said Synairgen CEO Richard Marsden.
"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, Marsden said the ability to identify patients who could benefit from an inhaled antiviral 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."