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RNS Number : 8317S
Synairgen plc
28 June 2018
Press release
Synairgen plc
('Synairgen' or the 'Company')
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 is a progressive lung
disease punctuated by periods of exacerbation involving acute
worsening of symptoms, which have major implications for both the
patient and the healthcare system. 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 patients(3) (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 immunity(4) .
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 been found to be well tolerated in COPD and the impact
of colds is more frequent and greater in COPD patients than in
asthma, these results greatly increase our confidence in the
potential for SNG001 to provide clinical benefit in the second part
of this trial, where we will look at the effects of treatment in
patients with a confirmed respiratory virus infection."
The second part of SG015, scheduled to cover the 2018/19 winter
cold virus season, is designed to measure various efficacy
endpoints and biomarker levels in patients with a respiratory
virus. This part of the trial aims to enrol 80 patients with
confirmed respiratory viruses, who will be randomised to receive
either inhaled SNG001 or placebo.
This announcement contains inside information as defined in
Article 7 of the Market Abuse Regulation No. 596/2014 ('MAR')
For further enquiries, please contact:
Synairgen plc
Richard Marsden, Chief Executive Officer
John Ward, Finance Director
Tel: + 44 (0) 23 8051 2800
finnCap
Geoff Nash, Max Bullen-Smith (Corporate Finance)
Stephen Norcross (Corporate Broking)
Tel: + 44 (0) 20 7220 0500
Consilium Strategic Communications (Financial Media and
Investor
Relations)
Mary-Jane Elliott / Sukaina Virji / Laura Thornton
synairgen@consilium-comms.com
Tel: +44 (0) 20 3709 5701
Notes for Editors
About SNG001
SNG001 is an inhaled interferon beta (IFN-beta) therapeutic
candidate, which has been shown to 'orchestrate' antiviral defence
mechanisms to protect COPD lung cells against cold and flu viruses
in in vitro models.
In addition, independent research published by Nature
Communications suggests that the increased risk of pneumonia
associated with the use of inhaled corticosteroids to treat
exacerbations in COPD could be due to suppression of interferons,
and proposes that inhaled IFN-beta therapy could be
protective.(5)
About Synairgen
Synairgen is a respiratory drug discovery and development
company founded by University of Southampton Professors Stephen
Holgate, Donna Davies and Ratko Djukanovic. The business, focused
primarily on asthma and COPD, uses its differentiating human
biology BioBank platform and world-renowned international academic
KOL network to discover and develop novel therapies for respiratory
disease. Leveraging its scientific and clinical facilities at
Southampton General Hospital, the Company uses in vitro and ex vivo
models to progress opportunities into clinical development. The
BioBank of human samples is used in these models to increase
confidence in the likelihood of successful drug development.
Synairgen is currently running a two-part Phase II trial
evaluating SNG001, the Company's wholly-owned inhaled interferon
beta (IFN-beta) therapeutic candidate. The Phase II trial, called
SG015, has been designed to assess the safety of SNG001in COPD
patients and its clinical benefit in these patients when they have
a cold or flu infection, a major driver of COPD exacerbations.
Core to Synairgen's business strategy is the realisation of
value via licensing transactions. In August 2015 the Company
entered into a collaboration with Pharmaxis to develop an oral
LOXL2 inhibitor to reduce fibrosis in patients with idiopathic
pulmonary fibrosis (IPF). In December 2017 the collaboration
agreement was amended as Pharmaxis took on full responsibility for
the programme, with Synairgen receiving a GBP5 million upfront
payment and circa 17% of any future partnering proceeds from all
fibrotic indications.
Synairgen is quoted on AIM (LSE: SNG). For more information
about Synairgen, please see www.synairgen.com
References
1. Department of Health. An Outcomes Strategy for Chronic
Obstructive Pulmonary Disease (COPD) and Asthma in England.
Published July 2011.
2. Johnston NW, et al. Colds as predictors of the onset and
severity of COPD exacerbations International Journal of COPD
2017:12: 839-848
3. Wilkinson TMA, et al. A prospective, observational cohort
study of the seasonal dynamics of airway pathogens in the aetiology
of exacerbations in COPD Thorax 2017;0:1-9.
Doi:10.1136/thoraxjnl=2016-209023
4. Hilzendeger C, et al. Reduced sputum expression of
interferon-stimulated genes in severe COPD. Int J Chron Obstruct
Pulmon Dis. 2016 Jun 30;11:1485-94. doi: 10.2147/COPD.S105948.
5. Singanayagam A, et al. Corticosteroid suppression of
antiviral immunity increases bacterial loads and mucus production
in COPD exacerbations. Nature Communications. 2018. Doi:
10.1038/a41467-018-04574-1
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END
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