Synairgen phase I study yields positive results

Southampton, UK-based Synairgen, the drug discovery company focused on asthma and chronic obstructive pulmonary disease (COPD), has revealed a successful outcome of its first Phase I clinical study for inhaled interferon beta ('IFNß'), which it is developing as a potential treatment for asthma and COPD.

36 allergic non-asthmatic volunteers received inhaled IFNß 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 IFNß 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 IFNß 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 IFNß delivery to the lungs,' said Ratko Djukanovic, the trial's 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 one further Phase I study of INFß in asthmatic volunteers prior to a 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.'