Synairgen plc
15 November 2005
SYNAIRGEN PLC
INTERFERON-Beta ENTERS CLINIC FOR NOVEL USE
IFN-Beta to be used to treat virus-induced asthma exacerbations
Southampton, UK - Synairgen plc ('Synairgen' or the 'Company'), the drug
discovery company focused on the underlying causes of asthma and chronic
obstructive pulmonary disease (COPD), is pleased to announce that the first
subject has been enrolled into the Phase I clinical trial to assess the safety
and tolerability of inhaled interferon-Beta ('IFN-Beta').
The rhinovirus or cold virus is the most common trigger for the worsening of
asthma symptoms (otherwise known as an asthma exacerbation), particularly among
severe asthmatics. Building on successful data derived from its proprietary in
vitro models of the disease, Synairgen is investigating a novel application of
inhaled IFN-Beta to reduce exacerbations caused by the cold virus. Currently
there are no satisfactory treatments available to address this significant unmet
need in asthma.
The total cost of asthma in the United States is $16bn per annum, and this
includes some $4.1bn for emergency department visits and in-patient care. It has
been shown that c.10% of the asthmatic population who suffer from severe asthma
take up over 50% of the total cost of the disease. Genentech's Xolair(R) is the
first drug aimed primarily at the allergic portion of the severe population.
If the planned trials are successful, it is intended that Synairgen's inhaled
IFN-Beta will provide a first line of defence for many of the asthmatic
population for whom there is currently no effective treatment for cold-induced
episodes.
Professor Stephen Holgate, one of the academic founders and non-executive
directors of Synairgen, said, 'Asthmatics live on a knife edge fearing an
exacerbation. Our models of human disease have shown that asthmatic airways
produce little or no IFN-Beta which acts as a defence against the virus's
ability to replicate. This has led us to develop an inhaled IFN-Beta programme
and we hope to demonstrate the utility of this approach in a proof of concept
study of therapeutic efficacy which will follow these safety studies'.
'There is a large market for a treatment capable of preventing
rhinovirus-induced asthma exacerbations,' added Richard Marsden, Managing
Director of Synairgen. 'There are two million emergency department visits due to
asthma per year in the US alone; at least 50% of these visits will have been
triggered by the common cold. In addition, with the rise of 'alternate site' (ie
non hospital) treatment, many more asthma sufferers seek help from their general
practitioner or specialist physician in the Doctor's Office setting.
'We are optimistic that an inhaled IFN-Beta therapy could fill a significant gap
in the chest physician's armoury.'
The trial is being conducted at the University of Southampton by Professor Ratko
Djukanovic (one of Synairgen's founders) and will comprise 27 subjects. The
outcome of this study will determine the extent of further safety studies
needed.
Injectable IFN-Beta is used to treat multiple sclerosis and various forms are
currently marketed by Biogen IDEC Inc, Schering AG., Pfizer Inc., and Serono SA.
-Ends-
For further information, please contact:
Synairgen Tel: 02380 512 800
Richard Marsden, Managing Director
Hogarth Partnership Tel: 020 7357 9477
Melanie Toyne-Sewell
Georgina Briscoe
Notes to Editors
1. Background to the Company
Synairgen was founded by Professors Stephen Holgate, Donna Davies and Ratko
Djukanovic (the 'Founders'), a world-renowned respiratory research team from the
University of Southampton (the 'University'), and spun-out from the University
in June 2003. In October 2004 the Company floated on AIM, raising £10.0 million
(£9.0 million net of expenses) to enhance its research and development
capabilities and invest in its proprietary programmes.
2. Asthma
• In the United States, there are approximately 20 million asthmatics(1).
• An annual economic cost to the US of $16bn (1).
• There are 1,900,000 emergency department visits due to asthma per year
in the US (1).
• The cost of emergency department visits and in-patient care in relation
to asthma is $4.1bn(1).
• There is evidence that as many as 80% of asthma exacerbations which
resulted in emergency department visits can be associated with RV
infections (3).
• It has been shown that the severest 10% of the asthmatic population take
up over 50% of the total cost of the disease(2).
Information about common colds and rhinovirus (RV).
• Adults get an average of two to four colds per year, mostly between
September and May(4).
• Young children suffer from an average of six to eight colds per year(4).
• Asthmatics contract as many colds as non-asthmatics(5).
• Asthmatics have similar upper respiratory tract (nose and throat)
symptoms as non-asthmatics(5).
• Asthmatics frequently suffer lower respiratory tract (the airways in the
lung) infections(5).
Xolair(R) the first treatment for severe asthmatics
Xolair marketed by Genentech in the US costs some $10,000 per patient per year.
Xolair has been shown to reduce the frequency of asthma exacerbations and is
targeted at severe asthmatics whose asthma is primarily caused by the allergic
pathway.
References
1 American Lung Association. Trends in Asthma Morbidity and Mortality.
2005 www.lungusa.org
2 P.J. Barnes, B. Jonsson, J.B. Klim. The Costs of Asthma. Eur Respir J
1996 9, 636-642
3 S. Kling et al, Persistence of Rhinovirus RNA after asthma
exacerbations in children. Clin Exp Allergy 2005 May 35 (5) 672-8
4 Cold and Flu Guidelines: The Common Cold www.lungusa.org
5 J.M. Corne et al Frequency, severity and duration of rhinovirus
infections in asthmatic and non-asthmatic individuals: a longitudinal
cohort study. Lancet 2002 Mar 9; 359 (9309):831-4
This information is provided by RNS
The company news service from the London Stock Exchange
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