Portfolio news 2010
Synairgen plc - IFN-beta patent granted in Europe
06 May 2010
Synairgen plc (LSE: SNG), the respiratory drug discovery and
development company with a particular focus on viral defence in
asthma and chronic obstructive pulmonary disease ('COPD'), is
pleased to announce that the patent for inhaled interferon beta
('IFN-beta') to treat rhinovirus infections in asthma and COPD has
been granted in Europe.
The patent is part of a patent portfolio owned by the University
of Southampton, which is exclusively licensed to Synairgen.
Richard Marsden, CEO of Synairgen, commented,
"The European patent grant and the US patent granted last year are
key ingredients in the out-licensing package."
For further information, please
contact:
Synairgen
plc
Tel: +44 (0) 23 8051 2800
Richard Marsden, Chief Executive Officer
John Ward, Finance Director
Matrix Corporate
Capital
Tel: + 44 (0)20 3206 7000
Alastair Stratton
Anu Tayal
Threadneedle
Communications
Tel: + 44 (0) 20 7653 9850
Graham Herring
Josh Royston
Notes for Editors
About Synairgen
Synairgen is a drug discovery
and development company founded by Professors Stephen Holgate,
Donna Davies and Ratko Djukanovic, focused on identifying and
out-licensing new pharmaceutical products which address the
underlying causes of asthma and COPD. Synairgen is listed on AIM
(LSE: SNG).
Synairgen's researchers use advanced cell models incorporating
human tissue and cells drawn from its biobank of clinical samples,
which are obtained from well-characterised healthy control, asthma
or COPD volunteers.
For more information about Synairgen please see
www.synairgen.com.
Synairgen's interferon beta ('IFN-beta')
programme
Synairgen is developing inhaled IFN-beta as
a therapy to combat virus-induced asthma and COPD
exacerbations.
Using in vitro human models, it was discovered that epithelial
cells (cells which line the airways) from both subjects with
asthma1 and COPD have significantly weaker antiviral responses to
the common cold virus than healthy control subjects. The addition
of low levels of IFN-beta into the models restored antiviral
responses (simulating aerosolised IFN-beta therapy). This suggests
that local delivery of IFN-beta to the lungs could limit the spread
of virus to lungs in subjects with respiratory disease and the
consequent worsening of their symptoms.
Synairgen has entered into a supply and licence agreement for a
patent-protected formulation of IFN-beta from the Rentschler Group
in Germany.
SG004
SG004, a placebo-controlled Phase I study in controlled asthmatics
taking inhaled corticosteroids, used the Company's exclusively
in-licensed Rentschler formulation of inhaled IFN-beta and was
designed to establish its safety at four different dose levels over
a 14 day period. In addition biomarker activity (see below) was
measured as an indicator of antiviral activity. The trial was
completed in September 2009 and showed that inhaled IFN-beta was
well tolerated, causing no adverse effect on standard measures of
lung function and inflammation.
SG004 Biomarkers
Neopterin is a
well-recognised marker of IFN-beta antiviral activity. Having
developed and validated a test for measuring neopterin in airway
secretions, analysis of the SG004 samples showed statistically
significant and dose dependant increases in neopterin levels,
indicating that antiviral defences had been activated in the lung.
Furthermore, there were increases of between 4-fold and 64-fold in
the gene expression of three antiviral proteins (MxA, 2-5-OAS and
IP-10) in the lung cells of the asthmatic volunteers 24 hours after
inhaling IFN-beta, indicating that inhaled IFN-beta stimulated a
broad antiviral response
in the lung.
Activity of IFN-beta against 2009 H1N1 ('swine flu') and
seasonal influenza Laboratory experiments were undertaken in 2009
for Synairgen by the Health Protection Agency's Centre for
Emergency Preparedness and Response (Porton Down, Salisbury) which
confirmed the antiviral potency of IFN-beta against 2009 H1N1. In
the experiments lung cells were grown in cell culture and then
exposed to the 2009 H1N1 (Strain: Influenza
A/California/04/2009(H1N1)), resulting in around 70% of cells
becoming infected. In the presence of IFN-beta, the proportion of
cells infected with the virus was reduced by at least 94% over 3
experiments.
Synairgen has undertaken similar in vitro experiments which also
confirm the antiviral potency of IFN-beta against seasonal
influenza.
SG005
SG005 is a placebo-controlled Phase II study of inhaled interferon
beta ('IFN-beta') for the treatment of exacerbations of asthma
caused by respiratory viruses including influenza. Following on
from the discovery that IFN-beta significantly reduced the ability
of influenza to infect lung cells SG005 was broadened to include
patients who contract influenza as well as common cold viruses. The
first volunteers were entered into the study on 31 March and the
trial is expected to be completed during the summer of 2011.
Patents granted
The patents for inhaled
IFN-beta to treat rhinovirus infections in asthma and COPD were
granted in the USA in August 2009 and in Europe in May 2010. The
patents form part of a patent portfolio owned by the University of
Southampton, which is exclusively licensed to Synairgen.
Asthma statistics
-
There are approximately 23 million asthmatics in the USA
- The economic cost to the USA
of asthma is projected to be $20.7 billion for 2010
- Asthma accounts for 1.7
million emergency department visits per year in the USA
- The cost of emergency
department visits and in-patient care in relation to asthma in the
USA for 2010 is projected to be $5.5 billion
- The average duration of a
hospitalisation for an asthma exacerbation in the USA is 2.7 days
at a cost of $9,078
- 50% of the total cost of the
asthma is apportioned to 10% of the asthmatic population with the
severest disease
COPD statistics
- COPD includes chronic
bronchitis and emphysema
- COPD is forecast to be the
third leading cause of death worldwide (after heart attack and
stroke) by 2030
- 12 million adults in the USA
have reported a physician diagnosis of COPD. However, as many as 24
million adults have some evidence of impaired lung function,
implying an under-diagnosis of this disease
- The economic cost to the USA
of COPD is projected to be $49.9 billion for 2010
- Hospital care is projected
to cost $13.2 billion for 20103 and in 2006 there were
672,000 hospitalizations for COPD in the USA
Rhinovirus (common cold virus) and exacerbations (worsening of
symptoms) of asthma
- Adults get an average of two to
four colds per year, mostly between September and May. Young
children suffer from an average of six to eight colds per
year
- Rhinovirus infections are the
major cause of asthma exacerbations, accounting for 50% to 80% of
all such attacks in both children and adults
Influenza
-
In the USA, an estimated 25-50 million cases of the flu are
currently reported each year - leading to 150,000 hospitalizations
and 30,000-40,000 deaths yearly
References
- P. Wark et al. Asthmatic bronchial epithelial cells
have a deficient innate immune response to infection with
rhinovirus.J Exp Med. 2005; 201: 937-947
- American Lung Association. Trends in Asthma
Morbidity and Morality. February 2010
www.lungusa.org
- National Heart, Lung and Blood Institute. Morbidity
and Mortality 2009 Chart Book on Cardiovascular, Lung and Blood
Diseases
- V. Krishnan et al. Mortality in patients
hospitalized for asthma exacerbations in the United States. Am J
Respir Crit Care Med 2006 174, 633-638
- P.J. Barnes, B. Johnson, J.B. Klim. The Costs of
Asthma. Eur Respir J 1996 9, 636-642
- World Health Organisation website
- American Lung Association. Trends in COPD (Chronic
Bronchitis and Emphysema) Morbidity and Morality. February 2010
www.lungusa.org
- Centers for Disease Control and Prevention. National
Center for Health Statistics. National Health & Nutrition
Examination Survey, 1988-1994
- American Lung Association: Cold and Flu Guidelines:
The Common Cold www.lungusa.org
- J.T. Kelly et al. Host immune responses to rhinovirus:
Mechanisms in asthma. J Allergy Clin Immunol 2008; 122:
671-682
- www.fluFACTS.com