REG - Synairgen plc - Positive Findings from SG015 Tri-al Analysis

SynairgenAnnouncement

07/09/2022 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20220907:nRSG5162Ya&default-theme=true

RNS Number : 5162Y  Synairgen plc  07 September 2022

 

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
(https://clinicaltrials.gov/ct2/show/NCT03570359?term=SNG001&draw=2&rank=4)
).

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  (#_ftn1) ))

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').

For further enquiries, please contact:

Synairgen plc

Brooke Clarke, Head of Communications

Media@synairgen.com (mailto:Media@synairgen.com)

Tel: + 44 (0) 23 8051 2800

 

finnCap (NOMAD and Joint Broker)

Geoff Nash, Charlie Beeson (Corporate Finance)

Alice Lane, Sunil de Silva (ECM)

Tel: + 44 (0) 20 7220 0500

 

Numis Securities Limited (Joint Broker)

James Black, Freddie Barnfield, Duncan Monteith

Tel: + 44 (0) 20 7260 1000

 

Consilium Strategic Communications (Financial Media and Investor Relations)

Mary-Jane Elliott, Namrata Taak, Lucy Featherstone

cscsynairgen@consilium-comms.com (mailto:cscsynairgen@consilium-comms.com)

Tel: +44 (0) 20 3709 5700

 

MKC STRATEGIES, LLC (US Media Relations)

Mary Conway

MConway@MKCStrategies.com (mailto:MConway@MKCStrategies.com)

Tel: +1 516-606-6545

 

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.

 1  (#_ftnref1) Company press release, 8 September 2020
https://synairgen.ams3.digitaloceanspaces.com/200908-sg015-press-release-final.pdf

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  RESGZGGLMVKGZZZ