Synairgen plc - Positive interim analysis of SNG001 in COPD
- SNG001 well tolerated in this older population with a significant co-morbidity (COPD)
- Strong interferon driven antiviral biomarker response
- Data support future progression of SNG001 for exacerbating COPD patients
- Positive data supportive of SNG001 COVID-19 programme
SNG001 was well tolerated during the treatment period in a study population that was elderly (mean age 66 years) and suffering from reduced respiratory function, as measured by forced expiratory volume in one second (FEV1) (59% of predicted value). The percentage of on-treatment adverse events was similar in the placebo and SNG001 treatment groups (48.1% versus 45.6%, respectively), with treatment-related adverse events being more frequent in the placebo group (25%) compared to the SNG001 group (15.8%). This safety data add to the safety database for SNG001, supporting
· Antiviral activity
Over the treatment period, lung antiviral responses to viral infection were significantly enhanced in patients receiving SNG001 compared to those on placebo, as assessed by measuring increases in the gene expression of interferon beta-dependent antiviral biomarkers MX1 (p=<0.001) and OAS1 (p=<0.001) in lung (sputum) cells. Analysis of blood biomarkers is ongoing.
· Clinical endpoints
The impact of viral infection on COPD patients in the trial was most evident on peak expiratory flow rate (PEFR), a measure of lung function, and patient-reported symptoms assessed using the Breathlessness Cough and Sputum Score (BCSS), and was particularly apparent in exacerbating patients (i.e. patients already requiring treatment with oral corticosteroids and/or antibiotics at the time of randomisation, who represented one third of patients enrolled).
Exacerbating patients who received SNG001 had significantly better lung function during the treatment period (difference in change from baseline morning PEFR between patients receiving SNG001 and placebo over days 2-15 was 25.5L/min; p=0.041). Although there was no significant difference in total BCSS in this group over the treatment period, there was a trend for the breathlessness component of the score, suggesting that patients may have recovered more rapidly if they received SNG001 rather than placebo.
Viral infections had less impact on non-exacerbating patients and there were no significant treatment effects.
A range of common respiratory viruses including rhinovirus, influenza, adenovirus, respiratory syncytial virus (RSV), human metapneumovirus (HMPV), parainfluenza and coronavirus (the four strains that cause common cold symptoms, but not SARS-CoV-2, the virus that causes COVID-19) were identified in nasopharyngeal and/or sputum samples from the COPD patients in this trial. This is relevant because COVID-19 patients can be coinfected with other respiratory viruses such as influenza. SNG001 has demonstrated antiviral activity against multiple viruses in cell-based assays. Further virology work is being conducted.
Next steps for COPD
COPD exacerbations are the second most common cause of unplanned hospital admission in
Next Steps for COVID-19
"Our immediate priority is to progress SNG001 as a therapeutic for COVID-19 and, as such, our COPD programme will remain paused. We are, nevertheless, pleased to provide further evidence that supports SNG001 as a potential treatment for COVID-19 through the safety, biomarker, and efficacy data generated from patients in this interim review of the COPD trial."
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Notes for Editors
COPD is a progressive lung disease, punctuated by periods of exacerbation characterised by acute worsening of symptoms which require treatment with oral corticosteroids and/or antibiotics, which have major implications for both the patient and the healthcare system. COPD exacerbations are the second most common cause of unplanned hospitalisation in
About SG015 - COPD Trial
The second part of the trial included biomarker outcome measures (expression of interferon-stimulated antiviral genes in cells from sputum and proteins in blood samples such as CXCL10) and a number of clinical outcome measures, including changes in the Breathlessness, Cough and Sputum Score (BCSS), and changes in peak expiratory flow rate (PEFR, a measure of lung function).
Patients were stratified at the time of randomisation into two groups according to whether they were already experiencing an exacerbation of their COPD symptoms requiring treatment with oral corticosteroids and/or antibiotics (exacerbating patients), or whether they just had a viral infection (non-exacerbating patients). Some 32% of patients were exacerbating patients. The aim of treatment was to accelerate recovery in exacerbating patients and prevent a deterioration in non-exacerbating patients.
Recruitment into the trial commenced in earnest in
About SG016 - COVID-19 Trial
On the 20th
COVID-19, caused by the SARS-CoV-2 virus, is a global threat and there is an urgent need to assess new treatments to prevent and effectively treat the severe lower respiratory tract illness that can occur with this disease. Older people and those with co-morbidities such as heart and lung complications or diabetes are at greatest risk of developing severe or fatal disease.
Interferon beta (IFN-beta) applicability to COVID-19
Interferon beta is a naturally- occurring protein, which orchestrates the body's antiviral responses. There is evidence that deficiency in IFN-beta production by the lung could explain the enhanced susceptibility in 'at-risk' patient groups to developing severe lower respiratory tract (lung) disease during respiratory viral infections. Furthermore, viruses, including coronaviruses such as SARS-CoV-2 and MERS-CoV, have evolved mechanisms which suppress endogenous IFN-beta production, thereby helping the virus evade the innate immune system. The addition of exogenous IFN-beta before or during viral infection of lung cells either prevents or greatly diminishes cell damage and viral replication, respectively.
Previously, two Phase II clinical trials in asthmatic patients showed that inhaled SNG001 treatment activated antiviral pathways in the lung, along with improving lung function in patients with a respiratory viral infection.
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