Phase II Clinical Trial Update in Patients with COPD
Clinical trial data to date shows impact of viruses on COPD patients
Southampton, UK – 24 July 2019: Synairgen (LSE: SNG), the respiratory drug discovery and development company, today announces an update on the Company’s wholly-owned inhaled interferon beta (IFN-beta) programme, currently in a Phase II clinical trial, which is aimed at countering the adverse effects of common cold and influenza viruses in patients with chronic obstructive pulmonary disease (COPD).
The trial is progressing well in 15 centres around the UK and is scheduled to complete in the winter 2019-2020 virus season.
Prof. Tom Wilkinson, Chief Investigator for the trial, said: “COPD exacerbations caused by cold and influenza viruses represent a significant health risk, particularly in the winter virus season1. Patients with COPD exacerbations are the second most likely group of patients to be hospitalised in England for unplanned events2.
“With no effective broad-spectrum antiviral treatment on the market, Synairgen’s inhaled IFN-beta may provide a novel approach for COPD patients, with the potential to greatly improve the patient's defences against viral infection, reduce exacerbations, increase quality of life and reduce hospitalisations.”
An analysis of all the patients dosed to date, as a single group regardless of treatment (the study will not be unblinded until the end of the trial), shows that cold and flu infections are having a considerable impact on symptoms in COPD patients, as assessed using the validated Breathlessness, Cough and Sputum Score (BCSS)3. A mean decrease in BCSS score > 1 represents substantial symptomatic improvement4. As we are seeing an increase in mean BCSS score >2, we have the potential to demonstrate a significant treatment effect. These changes contrast with the most recent asthma trial, where colds had less impact on patients.
The Company is also pleased to report that the rapid point-of-care test, being used to confirm that a patient has a viral infection, is ensuring that only the correct patients are being enrolled. The test ensures that only those patients for whom IFN-beta therapy may be effective are being dosed, thereby increasing the chance of the drug showing a beneficial effect. To date, approximately 35% of patients presenting with symptoms have tested positive for a viral infection. Viruses detected include rhinovirus, influenza, RSV, parainfluenza and coronavirus infections.
Richard Marsden, CEO of Synairgen, said: “Aided by the rapid point-of-care test, the trial is successfully capturing marked changes in COPD symptoms in patients with confirmed common cold and influenza virus infections. We have previously shown that inhaled IFN-beta boosts the lungs’ antiviral defences in COPD patients and the magnitude of the symptom changes being observed so far in the current trial puts us in a good position to determine the potential benefit of inhaled IFN-beta in this patient population.”