Synairgen plc Synairgen Safety Data with SNG001 in COPD Patients (2120S)
June 22 2018 - 2:00AM
UK Regulatory
TIDMSNG
RNS Number : 2120S
Synairgen plc
22 June 2018
Press release
Synairgen plc
('Synairgen' or the 'Company')
Synairgen Reports Positive Safety Data with SNG001 in COPD
Patients
Southampton, UK - 22 June 2018: Synairgen (LSE: SNG), the
respiratory drug discovery and development company, announces that
interim safety data from the ongoing Phase II trial of its
antiviral therapy SNG001 in patients suffering from chronic
obstructive pulmonary disease (COPD) shows that SNG001 is being
well tolerated.
Synairgen's two-part Phase II trial, called SG015, has been
designed to assess the safety of 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. The Drug Safety Monitoring Committee has
reviewed the safety data from the first part and has approved
progression to the second part of the trial.
Richard Marsden, Chief Executive of Synairgen, said: "COPD is a
very severe disease and it is reassuring to establish that SNG001
is well tolerated in these patients. We look forward to seeing the
biomarker analysis, which is due in the near term to see whether
SNG001 has switched on the antiviral defence mechanisms. Changes in
biomarkers translated into clinical benefit in Phase II trials in
asthma. Therefore, if we see similar biomarker changes in this
study, it will greatly increase our confidence in the potential of
SNG001 in COPD, where colds and flu can cause more severe symptoms
than in asthma."
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.
SNG001, which is wholly-owned by Synairgen, 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.(1)
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.(2) The risk that a cold will cause an exacerbation
of COPD is around 50%(3) and could be even higher in certain
at-risk patients(4) (considerably higher than for asthmatic
patients, where the risk that a cold will cause an exacerbation is
less than 10%).
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 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. 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. Singanayagam A, et al. Corticosteroid suppression of
antiviral immunity increases bacterial loads and mucus production
in COPD exacerbations. Nature Communications 2018. Doi:
10.1038/s41467-018-04574-1
2. Department of Health. An Outcomes Strategy for Chronic
Obstructive Pulmonary Disease (COPD) and Asthma in England.
Published July 2011
3. Johnston NW, et al. Colds as predictors of the onset and
severity of COPD exacerbations. International Journal of COPD
2017:12: 839-848
4. 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
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END
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