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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 ).
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').
For further enquiries, please contact:
Synairgen plc
Brooke Clarke, Head of Communications
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
Tel: +44 (0) 20 3709 5700
MKC STRATEGIES, LLC (US Media Relations)
Mary Conway
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] Company press release, 8 September 2020
https://synairgen.ams3.digitaloceanspaces.com/200908-sg015-press-release-final.pdf
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