Synairgen Phase II Clinical Trial Commences Dosing in Patients With COPD
Southampton, UK – 7 February 2018: Synairgen (LSE: SNG), the respiratory drug discovery and development company, today announces 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).
COPD is a progressive lung disease punctuated by periods of exacerbation involving acute worsening of symptoms, which have major implications for both the patient and the healthcare system. COPD exacerbations are the second most common cause of hospitalisation1. The risk that a cold will cause an exacerbation of COPD is around 50%2 and could be even higher in certain at-risk patients3 (considerably higher than for asthmatic patients, where the risk of an exacerbation occurring is less than 10%).
SNG001, which is wholly-owned by Synairgen, is an inhaled interferon beta (IFN-beta) therapeutic candidate which has 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, has been designed to assess the effects of SNG001 in COPD patients.
The first part of the SG015 trial involves dosing 10 COPD patients who have no evidence of viral infection to examine levels of antiviral biomarkers in response to SNG001. The aim is to assess whether administering SNG001 boosts antiviral defence mechanisms in the lung in the absence of a respiratory virus. The first part of the trial is scheduled to complete in Q1 2018.
The second part of the SG015 trial is designed to measure various efficacy endpoints and biomarker levels in patients with a respiratory virus. In this part, 80 patients will be randomised to receive either inhaled SNG001 or placebo. This part of the trial will bridge the end of the 2017/2018 winter/spring virus season and the 2018 virus season which starts in the autumn.
Richard Marsden, Chief Executive Officer of Synairgen, said: “We are excited to begin evaluating SNG001 in COPD, where exacerbations are a significant health risk and economic burden. 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.”