Date: 2012-04-19
Type of information:
phase: 2
Announcement: results
Company: Synairgen (UK)
Product: SNG001 (inhaled interferon beta)
Action mechanism:
Disease: protection of asthmatic patients from respiratory virus infections
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country:
Trial
details: The Phase II multi-centre, randomised, double-blind, placebo-controlled study recruited a broad spectrum of adult asthmatic patients, all of whom were taking inhaled corticosteroids and had a history of deteriorating symptoms when they contracted common respiratory viruses (primarily the common cold). 147 patients were randomised to receive either SNG001 or placebo for 14 days at the onset of cold symptoms.
134 out of the 147 patients (91%) who commenced treatment had confirmed colds as determined by the Jackson Cold Score and formed the modified intention to treat population (mITT). These patients are used for the analysis of efficacy.
A range of respiratory viruses were identified in nasal lavage and sputum samples, of which rhinoviruses represented 68% of detected viruses. Common cold symptoms tightly correlated with worsening asthma symptoms. Patients with worse underlying asthma (more intensively treated with routine asthma therapies) before onset of cold symptoms were more adversely affected by the cold than patients with less problematic asthma.
Approximately half the patients in the trial were categorised as falling within the highest two steps of the asthma spectrum as defined by the British Thoracic Society (BTS) and Global Initiative for Asthma (GINA) Guidelines (Steps 4 and 5). This group is estimated to represent some 10%-20% of the adult asthma population and is the most expensive to treat.
Latest
news: Synairgen has announced 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. The key trial findings in this ‘difficult to treat’ category were:
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.
- 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
