Synairgen Regulatory News (SNG)

29 Jul 2008 07:00



SYNAIRGEN PLC

('Synairgen' or the 'Company')

Commencement of Clinical Trial with Interferon Beta in Asthmatic Volunteers

Southampton, UK - 29 July 2008: Synairgen (LSE: SNG), the drug discovery company focused on asthma and COPD, is delighted to announce the commencement of its second clinical study of inhaled interferon beta ('IFN-beta') for the treatment of asthma.

The Phase I study, known as SG004, uses the Company's exclusively in-licensed formulation of inhaled IFN-beta and is designed to establish its safety at four different dose levels over a 14 day period in moderate asthmatic volunteers. It follows on from Synairgen's successful single dose safety study in allergic non-asthmatic volunteers.

There is an ever-increasing body of evidence that common cold viruses are the major trigger of exacerbations and hospitalisations of asthma and chronic bronchitis and emphysema (COPD). There is also increasing evidence that IFN-beta is the primary anti-viral protein known to be deficient in asthma. Synairgen's proprietary models of human disease have shown IFN-beta to have a marked anti-viral effect in asthma and COPD.

The SG004 study is being conducted by Synairgen in Southampton and at the Medicines Evaluation Unit in Manchester, both sites with renowned expertise in advanced respiratory trials. The first volunteer was entered into the study on 28 July and the trial is expected to be completed in the second quarter of 2009. 

Professor Stephen Holgate, Non-Executive Director and Co-Founder of Synairgen, said: 

"This is a critical study for our most advanced clinical development programme. Based on results from the previous study, we now look forward to establishing a dose range to take into our proof-of-concept Phase IIa trials in asthma and COPD, which are scheduled to start during the 2009/2010 winter season."

Ends

For further information, please contact:

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 chronic obstructive pulmonary disease. Synairgen is listed on AIM (LSE: SNG).

For more information about Synairgen please see www.synairgen.com.

Asthma statistics 

There are approximately 22 million asthmatics in the USA(1) 

The economic cost to the USA is $19.7 billion per year(1) 

Asthma accounts for 1,770,000 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 $4.7 billion(1) 

50% of the total cost of the asthma is apportioned to 10% of the asthmatic population with the severest disease(2) 

References

American Lung Association. Trends in Asthma Morbidity and Morality. 2007 www.lungusa.org 

P.J. Barnes, B. Johnson, J.B. Klim. The Costs of Asthma. Eur Respir J 1996 9, 636-642