Synairgen plc , announces positive data from its Phase II clinical trial. This pioneering trial investigated the potential for SNG001 (inhaled interferon beta) to protect asthmatics from respiratory virus infections (principally the common cold) that can spread to the lung, which are a major cause of worsening asthma symptoms. It is estimated that viral infection is associated with up to eight out of ten asthma-related emergency department visits.
There are 5.4 million asthmatics in the UK (Asthma UK) and 25.7 million in the USA (Centers for Disease Control and Prevention).
The study investigated SNG001 in a population of 134 adult asthma patients, representing 'mild-moderate' through to 'severe' asthmatics, who caught a cold. Patients with 'difficult to treat' asthma, being approximately half of the patients in the trial, benefitted significantly from SNG001 treatment. This category of patient is estimated to represent between 10% and 20% of all adult asthma sufferers.
The key trial findings in this 'difficult to treat' category were:
- Clinically important and statistically significant differences in favour of SNG001 as compared to placebo across recognised measures of asthma symptom severity and lung function including: - Prevention of worsening of asthma symptoms during the critical first week of infection and treatment as measured by the Asthma Control Questionnaire (sACQ) (p=0.004) - 65% reduction in the number of patients experiencing moderate exacerbations during the treatment period (p=0.01) - Reduced use of inhaled reliever bronchodilators on day 5 (p=0.02) and day 6 (p=0.01) - In the SNG001-treated patients there was a steady improvement in morning peak expiratory flow whilst in the placebo-treated patients there was an initial dip during the first week followed by an improvement (p=0.03) - SNG001 was well tolerated
Professor Stephen Holgate CBE, leading international asthma specialist and founder of Synairgen, said: "This is a really promising breakthrough for the future treatment of asthma and one of the most exciting developments that I have seen in years. This is the first clinical study which appears to demonstrate that, by boosting the antiviral defences of the lungs of asthmatics rather than trying to inhibit rapidly evolving viruses, we can limit the adverse effects of viral infection significantly to prevent worsening of asthma symptoms in a high risk group of patients.
This trial is an important milestone in the development of our SNG001 programme from its origins in research supported by the MRC, Asthma UK, the British Lung Foundation, the National Institute of Health Research and the University of Southampton, to today's exciting results in this 'real world' asthma study. Not only have we established the potential of SNG001 as a novel treatment for viral exacerbations in difficult to treat asthma but also a crucial link between viral infection, asthma symptoms and severity of disease.
These impressive findings across different endpoints, together with the accumulating body of evidence we have generated for other respiratory viruses such as influenza (Swine and Bird flu) and respiratory syncytial virus (RSV), strongly suggest that SNG001 has the potential to be used as a powerful broad spectrum antiviral respiratory drug in other lung diseases such as COPD and pandemic flu."
Leanne Metcalf, Assistant Director of Research at Asthma UK, says:
"This has the potential to be one of the biggest breakthroughs in asthma treatments in the past 20 years. We are incredibly excited by the possibilities this research could bring to reduce hospital admissions and deaths as a result of asthma attacks. Over 80% of asthma attacks are triggered by cold and flu viruses, and until now we haven't had any effective treatments that can stop this from happening. This clinical trial demonstrates the potential of this anti-viral drug to prevent asthma attacks for thousands of people with severe asthma. We are incredibly proud to have played a part in the realisation of this research programme which should benefit people with asthma in a really significant way."