RE: COPD Research/Trial27 Aug 2020 17:09
and the possitive biomarkers for the part 1 trial:
Synairgen Reports Positive Biomarker Data with SNG001 in COPD Patients
~ SNG001 shown to increase lung antiviral biomarkers
Southampton, UK – 28 June 2018: Synairgen (LSE: SNG), the respiratory drug discovery and development company, announces positive biomarker data from the ongoing Phase II trial of its antiviral therapy SNG001 in patients suffering from chronic obstructive pulmonary disease (COPD).
COPD exacerbations are the second most common cause of hospitalisation.1 The risk that a cold will cause an exacerbation of COPD is approximately 50%2 and could be even higher in certain at-risk patients3 (considerably higher than for asthmatic patients, where the risk that a cold will cause an exacerbation is less than 10%). There is also
evidence that COPD patients have impaired anti-viral immunity4.
Synairgen’s two-part Phase II trial, called SG015, has been designed to assess the safety of Synairgen’s wholly-owned programme, SNG001, in COPD patients and its clinical benefit in these patients when they have a cold or flu infection, a major driver of COPD exacerbations. The first part of SG015 involved dosing 10 patients who have COPD but no evidence of viral infection with the aim of assessing: (i) safety; and (ii) whether administering SNG001 boosts antiviral defence mechanisms in the lung in the absence of a respiratory virus, by means of biomarker analysis. On 22 June 2018 Synairgen announced that safety data had been analysed and SNG001 was well tolerated.
The antiviral biomarker analysis has now been completed and reveals that COPD patients inhaling SNG001 had significantly increased markers of antiviral activity. Sputum samples were taken before, during and after treatment. Gene expression was measured in cells extracted from sputum. The antiviral genes Mx1 and OAS1 were significantly higher at visits during the treatment phase (p<0.0001; gene expression was increased approximately 10-fold 5-fold respectively). These genes code for proteins that are known to interfere with viral replication. Other interferon stimulated genes which also have antiviral activity (CXCL10 (IP-10), GBP1 and IFIT2) were also upregulated.
Professor Stephen Holgate CBE, leading international lung disease specialist and founder of Synairgen, commented: “Respiratory virus infections, such as the common cold and flu, cause a significant proportion of COPD exacerbations when these viruses spread from the nose to the lung, causing inflammation and lung damage. The aim of treatment with inhaled SNG001 is to boost deficient anti-viral defences in the lung to prevent the spread of virus infections from the upper respiratory tract. These biomarker data support the proposed mechanism of action, showing that anti-viral activity was boosted by SNG001. Similar changes in biomarkers (Mx1 and OAS1) translated into improvements in lung function and reduced symptoms in Phase II trials in asthma. As SNG001 has bee
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