Synairgen Regulatory News (SNG)

22 Sep 2008 07:00



SYNAIRGEN PLC

('Synairgen' or the 'Company')

Biomarker indicates on target bioactivity of inhaled interferon beta (IFN-beta)

Southampton, UK, 22 September 2008: As part of its SG004 Phase I trial in moderate asthmatics Synairgen is monitoring predictors of efficacy by measuring biomarkers that will show if inhaled IFN-beta successfully restarts the body's natural anti-viral defences. 

During September 2008 Synairgen has tested samples collected in an earlier study of inhaled IFN-beta (SG003) for these biomarkers. This yielded a highly promising result, showing that the primary anti-viral biomarker (Neopterin) was raised in sputum levels 24 hours after dosing and remained unchanged in blood. This indicates that inhaled interferon was on target within the lung and the risk of unwanted systemic effects is low.

Commenting on these findings, Professor Stephen Holgate said, "These results are very exciting - they indicate that the strengthening of localised anti-viral defences by administering inhaled IFN-beta, as originally detected with our human in vitro asthmatic lung models, has translated directly into our first human studies. This gives us considerable confidence as we look to both the current and forthcoming clinical trials." 

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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 outlicensing 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.

SG004

SG004 is Synairgen's second clinical study of inhaled interferon beta ('IFN-beta') for the treatment of asthma. This Phase I study uses Synairgen'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 (SG003).

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 2008 and the trial is expected to be completed in the second quarter of 2009.

Biomarkers

A biomarker is a substance used as an indicator of a biologic state. In this case Neopterin is a drug activity biomarker that is objectively measured and evaluated as an indicator of pharmacologic responses to a therapeutic intervention (i.e. inhaled IFN-beta).