Synairgen plc, the respiratory drug discovery and development company with a particular focus on viral defense in asthma and chronic obstructive pulmonary disease (COPD), recently announced the commencement of its first Phase II study of inhaled interferon beta (IFN-beta) for the treatment of exacerbations of asthma caused by respiratory viruses, including influenza.

The Phase II study, known as SG005, uses the company’s exclusively in-licensed formulation of inhaled IFN-beta (SNG001) and aims to assess the efficacy and safety of inhaled SNG001 compared to placebo administered to asthmatic subjects after the onset of respiratory viral infection for the prevention or attenuation of asthma symptoms caused by respiratory viruses. Following on from the announcement in November 2009 that SNG001 significantly reduced the ability of influenza to infect lung cells, the SG005 study has now been broadened to include patients who contract influenza as well as common cold viruses.

Respiratory viral infections (primarily caused by common cold and influenza viruses) are recognized as the key triggers of exacerbations (rapid worsening of symptoms), which are the major contributor to the significant healthcare burden in asthma.

Confidence in the outcome of SG005 is strengthened by the results of Synairgen’s Phase I study in moderate asthmatics (SG004), which showed that inhaled SNG001 was well tolerated, and the biomarker analysis that confirmed activation of antiviral defenses in the lung.

The SG005 study is being conducted at a number of clinical trial sites in the United Kingdom. The first volunteers were entered into the study on March 31, and the trial is expected to be completed during the summer of 2011.

“We are delighted to have been able to commence this study on schedule,” said Richard Marsden, Chief Executive Officer of Synairgen. “In this study, we are aiming to correct an antiviral (IFN-beta) deficiency. We have shown the drug is well tolerated in a safety trial (SG004), and we have evidence that we have successfully primed the antiviral defenses; now we will test SNG001 in the presence of virus infections.”

Synairgen is a drug discovery and development company specializing in respiratory diseases with a focus on asthma and COPD. These diseases are rapidly growing causes of morbidity and mortality worldwide and represent an increasing and largely unmet medical need. The company focuses on the discovery of new drugs that address the underlying causes rather than the symptoms of asthma and COPD and in particular on virus-induced exacerbations of disease, which are associated with the majority of healthcare spending for these diseases. It aims to do this both in-house and via collaborations with industry partners, using its advanced in vitro cell models of human disease. The founding technology stems from at least 20 years of development in the laboratories at the University of Southampton led by Professors Stephen Holgate, Donna Davies, and Ratko Djukanovic.