Synairgen plc

('Synairgen' or the 'Company')

Synairgen announces positive findings from analysis of lung samples from the SG015 trial of SNG001 in virally infected COPD patients

Southampton, UK - 7 September 2022: Synairgen plc (LSE: SNG), the respiratory company developing SNG001, an investigational formulation for inhalation containing the broad-spectrum antiviral protein interferon beta, today announces positive data from additional assessments of lung sputum samples from its Phase 2 clinical trial of inhaled SNG001 in Chronic Obstructive Pulmonary Disease (COPD) patients with a confirmed respiratory viral infection (SG015, NCT03570359).

In early 2020, due to the emergence of SARS-CoV-2, Synairgen's SG015 trial in COPD patients was paused with 109 out of the targeted 120 patients recruited. An interim analysis of the data was reported in September 2020 which demonstrated that SNG001 boosted lung antiviral responses as assessed using sputum biomarkers, and led to a significant difference in the lung function of exacerbating patients.^[1]

Key findings of the additional assessment include:

·    Viral clearance from the lower respiratory tract

Sputum samples were collected where possible at study visits conducted during and after the 14-day dosing period. Assessment of viral clearance focused on the most frequently detected virus, human rhinovirus (HRV), which accounted for approximately 50% of infections. The results suggest that HRV was cleared more rapidly in patients treated with SNG001 than placebo with a statistically significant difference in the proportion of patients with detectable HRV in sputum at Day 7 (post hoc analysis).

·    Markers associated with secondary bacterial infections

In COPD exacerbations, sputum purulence and elevated levels of serum C-reactive protein (CRP) are associated with the presence of bacteria in the lower respiratory tract. In the second week of treatment, a greater proportion of patients in the placebo group had purulent sputum or elevated serum CRP.

Richard Marsden, CEO of Synairgen, said: "Our new data from COPD patients shows that SNG001 can accelerate viral clearance from the lung and builds on our existing data supporting SNG001's mechanism of action and our focus on severe viral lung infections. This additional assessment supports continued and further investigation of SNG001 as a possible broad-spectrum antiviral." 

The new findings are included in a presentation today entitled, "Don't be resistant to going antiviral: Could a broad-spectrum inhaled antiviral reduce the incidence of secondary bacterial chest infections?" by Richard Marsden at the World Anti-Microbial Resistance Congress in National Harbor, Maryland, USA.

The full results of the SG015 study will be submitted for publication in a peer reviewed journal.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No. 596/2014 ('MAR').

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Notes for Editors

About Synairgen

Synairgen is a UK-based respiratory company focused on drug discovery, development and commercialisation. The Company's primary focus is developing SNG001 (inhaled interferon beta) for the treatment of severe viral lung infections, including COVID-19, as potentially the first host-targeted, broad-spectrum antiviral treatment delivered directly into the lungs. SNG001 has been granted Fast Track status from the US Food and Drug Administration (FDA). Founded by University of Southampton Professors Sir Stephen Holgate, Donna Davies and Ratko Djukanovic in 2003, Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen, please see www.synairgen.com.

About SG015 - COPD Trial 

In 2018 Synairgen commenced a two-part COPD trial (SG015; NCT03570359) to assess initially, the safety and lung antiviral biomarker responses to SNG001 in the absence of viral infection. In the first part of the trial SNG001 was well tolerated in patients with moderate to severe COPD. A strong antiviral biomarker signal was also observed, which was comparable to the response previously observed in asthmatic patients. This paved the way for the second part of the trial, which was designed to dose 120 patients with confirmed, naturally-acquired respiratory virus infections.

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 January 2019 and was progressing well until the emergence of SARS-CoV-2, which made it difficult to test for virus and dose patients without potentially exposing them and research staff to SARS-CoV-2. Hence in March 2020 the trial was paused, with 109 out of the targeted 120 patients recruited. MHRA approval was received to run an unplanned interim analysis on the grounds that data from 109 COPD patients with confirmed viral infection could generate useful safety, biomarker and potentially efficacy data to support ongoing trials.