mal nicht zu COVID sondern zum eigentlichen Kernansatz von Synairgen: COPD
Synairgen plc Positive interim analysis of SNG001 in COPD
Synairgen announces positive data from interim analysis of SNG001 trial in COPD patients
- 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
Southampton, UK - 8 September 2020: Synairgen plc (LSE: SNG), the respiratory drug discovery and development company, today announces positive data from the interim analysis of its exploratory Phase II clinical trial of inhaled SNG001 in Chronic Obstructive Pulmonary Disease (COPD) patients with a confirmed respiratory viral infection.
Key findings
-- Safety
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 Synairgen's interactions with regulatory agencies in respect of COVID-19, where older age and poor lung function are risk factors.
-- 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.
-- Virology
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 England,(1) and occur most frequently in the winter virus season. The data from this trial, coupled with the data from the COVID-19 trial in hospitalised patients, provide a strong rationale for assessing SNG001 in COPD patients admitted to hospital with exacerbations from confirmed viral lung infections.
Next Steps for COVID-19
Synairgen is in discussions with a number of regulatory agencies worldwide to establish the regulatory route to the approval of SNG001 as a treatment for COVID-19. We are also working closely with the Company's manufacturing partners on scale-up activity and will provide a further update on these matters in due course.
Richard Marsden, CEO Synairgen, said: " COPD exacerbations are the second most common cause of unplanned hospitalisation in England, behind cardiovascular disease. These interim data from our first trial of SNG001 in COPD show that SNG001 could be a valuable novel therapeutic for exacerbating COPD patients. Overall, SNG001 has now been shown to raise the body's natural viral defences when challenged by a wide variety of respiratory viruses, indicating that it could be an important treatment in the coming virus season, where there may be coinfection with influenza and other viruses alongside 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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