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news.Synairgen, a respiratory drug discovery and development company, has initiated first Phase II study of inhaled interferon beta ('IFN-beta') for the treatment of exacerbations of asthma caused by respiratory viruses including influenza.
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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 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.
Synairgen said that the outcome of SG005 is strengthened by the results of Phase I study in moderate asthmatics (SG004), which showed that inhaled SNG001 was well tolerated and the biomarker analysis which confirmed activation of antiviral defences in the lung.
Reportedly, the SG005 study is being conducted at a number of clinical trial sites in the UK. The first volunteers were entered into the study on March 31 and the trial is expected to be completed during the summer of 2011.
Richard Marsden, CEO of Synairgen, said: “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 defences; now we will test SNG001 in the presence of virus infections.”