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RNS Number : 1176E
Synairgen plc
07 February 2018
Press release
Synairgen plc
('Synairgen' or the 'Company')
Phase II Clinical Trial Commences Dosing in Patients with
COPD
Southampton, UK - 7 February 2018: Synairgen (LSE: SNG), the
respiratory drug discovery and development company, today announces
that the first patients have been dosed in the Company's Phase II
trial of inhaled SNG001 in patients with 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 around 50%(2) and could be even higher in
certain at-risk patients(3) (considerably higher than for asthmatic
patients, where the risk of an exacerbation occurring is less than
10%).
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 a range of common viruses in in vitro
models.
Synairgen's two-part Phase II trial, called SG015, has been
designed to assess the effects of SNG001 in COPD patients.
The first part of the SG015 trial involves dosing 10 COPD
patients who have no evidence of viral infection to examine levels
of antiviral biomarkers in response to SNG001. The aim is to assess
whether administering SNG001 boosts antiviral defence mechanisms in
the lung in the absence of a respiratory virus. The first part of
the trial is scheduled to complete in Q1 2018.
The second part of the SG015 trial is designed to measure
various efficacy endpoints and biomarker levels in patients with a
respiratory virus. In this part, 80 patients will be randomised to
receive either inhaled SNG001 or placebo. This part of the trial
will bridge the end of the 2017/2018 winter/spring virus season and
the 2018 virus season which starts in the autumn.
Richard Marsden, Chief Executive Officer of Synairgen, said: "We
are excited to begin evaluating SNG001 in COPD, where exacerbations
are a significant health risk and economic burden. We have already
shown in in vitro models that SNG001 protects the lung cells of
COPD patients when infected with viruses that cause exacerbations
such as flu and the common cold. However, up until now, our ability
to identify those patients who may benefit from an inhaled
anti-viral therapy made the design of a prospective study
challenging. This has now changed with the development of a point-
of-care diagnostic tool which enables rapid confirmation of the
existence of a respiratory viral infection in COPD patients. This
enables us to treat only those patients who are infected with a
virus, significantly reducing the number of subjects required to
show the potential effect of SNG001."
-Ends-
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, James Thompson (Corporate Finance)
Stephen Norcross, Simon Johnson (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 medicine discovery and development
company founded by University of Southampton Professors Stephen
Holgate, Donna Davies and Ratko Djukanovic. Core to Synairgen's
business strategy is to create value around promising respiratory
assets and conduct licensing transactions. The Company has a proven
business model as demonstrated by its relationship with Pharmaxis.
Synairgen helped validate Pharmaxis's oral LOXL2 inhibitor
programme which is in clinical development to reduce fibrosis in
indications including liver fibrosis (NASH) and idiopathic
pulmonary fibrosis (IPF). Synairgen is progressing its lead
therapeutic candidate SNG001 towards a Phase II in COPD. The
Company uses its differentiating 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,
Synairgen uses in vitro and ex vivo models of respiratory disease
to progress programmes 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 quoted on
AIM (LSE: SNG). For more information about Synairgen, please see
www.synairgen.com.
About COPD
Chronic Obstructive Pulmonary Disease (COPD) is a lung condition
characterised by airflow limitation that is not fully reversible.
This airflow limitation is normally progressive and is associated
with an abnormal inflammatory response of the lung to pathogenic
stimulus. The majority of COPD is associated with long-term
cigarette smoking.
Symptoms of COPD include cough, excessive sputum production and
shortness of breath. Exacerbations of COPD are defined as the
worsening of COPD symptoms beyond normal day-to-day variations and
are associated with irreversible loss of lung function and,
therefore, accelerated disease progression.
Exacerbations severely impact on the patient's quality of life
(patients typically take a number of weeks to recover) and are a
major healthcare burden. Exacerbations are currently treated with
oral corticosteroids and antibiotics. Systemic administration of
corticosteroids is associated with unwanted side effects and there
is a drive to reduce antibiotic usage.
Respiratory viral infections, such as the common cold and flu,
are a major driver of exacerbations in patients with lung disease
when infections spread from the upper respiratory tract to the
lungs to worsen pre-existing lung inflammation. Furthermore,
particularly in COPD, there is growing evidence that viral
infections increase susceptibility to follow on bacterial
infections. Therefore, there is strong rationale to develop
anti-viral treatments to prevent or treat exacerbations of
COPD.
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
This information is provided by RNS
The company news service from the London Stock Exchange
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