Research Update
Synairgen plc
12 June 2007
SYNAIRGEN PLC
('Synairgen' or the 'Company')
Synairgen Announces Successful Outcome of Phase I Clinical Study
of Inhaled Interferon Beta
Southampton, UK - 12th June 2007: Synairgen plc (LSE:SNG), the drug discovery
company focused on asthma and COPD, today announces the successful outcome of
its first Phase I clinical study for inhaled interferon beta ('IFN-beta'), which
the Company is developing as a potential treatment for asthma and chronic
obstructive pulmonary disease ('COPD').
36 allergic non-asthmatic volunteers received inhaled IFN-beta or placebo at 3
different dose levels, using two different modes of delivery to the lung by
inhalation. The aim of this study was to assess the safety of inhaled IFN-beta
in a population of allergic volunteers who have some of the features of allergic
asthma, but do not have hyper-reactive airways, a feature that is characteristic
of asthma.
'We were pleased to see that within the dosage range we believe will be
efficacious, inhaled IFN-beta was well tolerated and the numerous biological and
physiological tests that we applied in the study did not show any adverse
biological effects. In the study we also took the opportunity offered by the
delivery device to optimise its application for IFN-beta delivery to the lungs,'
said Prof. Ratko Djukanovic, who was Principal Investigator for the trial.
Following the successful conclusion of this study (SG003) Synairgen has
discussed the ensuing development programme with the regulatory authorities,
with a view to commencing one further Phase I study of INF-beta in asthmatic
volunteers prior to undertaking the Phase IIa proof of concept study.
Richard Marsden, Managing Director of Synairgen, said, 'This is an important
milestone for Synairgen's lead programme. By studying the drug in allergic,
rather than 'normal', volunteers we set a higher threshold for success in the
trial than would normally be the case, building a strong foundation for us to
advance the programme.'
Ends
For further information, please contact:
Synairgen
Richard Marsden, Managing Director Tel: +44 (0) 23 8051 2800
John Ward, Finance Director
Hogarth Partnership
Melanie Toyne-Sewell Tel: +44 (0) 20 7357 9477
Notes for Editors
Synairgen
Synairgen is a drug discovery 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
chronic obstructive pulmonary disease. Synairgen is listed on AIM (LSE:SNG).
For more information about Synairgen please see www.synairgen.com.
Interferon Beta ('IFN-beta') in rhinovirus-induced asthma and COPD exacerbations
Synairgen is investigating a novel application of inhaled IFN-beta to reduce
cold virus-induced exacerbations in both asthma and COPD. This virus is a major
trigger for the worsening of both asthma symptoms (with up to eight out of ten
asthma related emergency department visits being associated with these viral
infections) and COPD exacerbations (up to 60% of all COPD exacerbations are
preceded by the common cold). Currently there are limited satisfactory
treatments available to address either of these significant unmet needs.
Asthma statistics
• There are approximately 20 million asthmatics in the USA
• The economic cost to the USA is $16 billion per year (1)
• Asthma accounts for 1,900,000 emergency department visits per year in
the USA (1)
• The cost of emergency department visits and in-patient care in relation
to asthma in the USA is $4.1 billion (1)
• Up to 80% of asthma exacerbations which result in emergency department
visits are associated with RV infections (2)
• 50% of the total cost of the asthma is apportioned to 10% of the
asthmatic population with the severest disease (3)
COPD statistics
• COPD is the 4th leading cause of death in the USA: 122,283 (2003) (4)
• The economic cost to the USA of COPD is $37.2 billion (5)
• Direct health expenditure on COPD in the USA is $20.9 billion
(asthma $11.5 billion) (5)
• Research by the SUPPORT investigators estimated the average cost of a
hospitalisation for a severe COPD patient to be $7,100 (6)
• The global market for COPD drugs is forecast to increase from $4 billion
to $7 billion by 2010 (7)
Information about common colds and rhinovirus (RV)
• Adults get an average of two to four colds per year, mostly between
September and May (8)
• Young children suffer from an average of six to eight colds per year (8)
• Asthmatics have similar upper respiratory tract (nose and throat)
symptoms as non-asthmatics (9)
• Asthmatics frequently suffer lower respiratory tract (the airways in the
lung) infections (9)
References
1. American Lung Association. Trends in Asthma Morbidity and Morality. 2005
www.lungusa.org
2. S. King et al, Persistence of Rhinovirus RNA after asthma exacerbations
in children. Clin Exp Allergy 2005 May 35 (5) 672-8
3. P.J. Barnes, B. Johnson, J.B. Klim. The Costs of Asthma. Eur Respir J
1996 9, 636-642
4. National Center for Health Statistics. Report of Final Mortality
Statistics, 2003
5. Morbidity & Mortality: 2004 Chart Book on cardiovascular, lung, and
blood diseases produced by National Heart, Lung, and Blood Institute
6. Connors AF Jr et al. Outcomes following acute exacerbation of severe
chronic obstructive lung disease. The SUPPORT investigators. Am J Respir Crit
Care Med 1996; 154:959-967
7. Espicom Business Intelligence: New Drug Futures: Respiratory Chapter
2006
8. Cold and Flu Guidelines: The Common Cold www.lungusa.org
9. J.M. Corne et al Frequency, severity and duration of rhinovirus
infections in asthmatic and non-asthmatic individuals: a longitudinal cohort
study. Lancet 2002 Mat 9; 359 (9309):831-4
This information is provided by RNS
The company news service from the London Stock Exchange