Synairgen plc - AZD9412 Clinical Trial Update
AZD9412 Clinical Trial Update
~ AstraZeneca to focus on key secondary endpoints with results expected in Q1 2017 ~
INEXAS clinical trial update from AstraZeneca:
"AstraZeneca has decided to stop the Phase IIa trial for AZD9412 based on an interim analysis, where an overall very low number of reported severe exacerbations could make primary endpoint conclusions difficult.
"The interim analysis confirmed the positive safety and tolerability profile seen in previous trials, and inhaled IFN-b remains an interesting treatment opportunity for patients with respiratory disease. AstraZeneca will now review the data and study design before deciding on the best way forward for the programme."
AstraZeneca will evaluate the key data collected from the INEXAS trial with a focus on the secondary endpoints that are most predictive of disease worsening to exacerbation, and
Background to the INEXAS trial:
In the trial, named INEXAS (details available on www.clinicaltrials.gov), asthma patients were dosed with placebo or AZD9412 at the onset of common cold symptoms. Previous research has shown that common colds can cause severe exacerbations of asthma and that boosting the antiviral defences of the lung with AZD9412 (inhaled interferon beta, an antiviral protein) during this time could prevent exacerbations from developing.
The INEXAS trial design:
The target number of patients recruited into any clinical trial is based on assumptions about the number of events and the anticipated benefit of the drug. In the INEXAS trial there have been far fewer exacerbations ("events") than anticipated possibly due to patient selection and environmental/regional factors, and therefore the trial's primary outcome could be hard to conclude within its current design.
For further information, please contact:
Richard Marsden, Chief Executive Officer
John Ward, Finance Director
FinnCap (NOMAD) Tel: +44 (0) 20 7220 0500
Geoff Nash, James Thompson (Corporate Finance)
Stephen Norcross, Simon Johnson (Corporate Broking)
Mary-Jane Elliott / Sue Stuart / Laura Thornton
[email protected] Tel: +44 (0) 20 3709 5701
Notes for Editors
Synairgen is a respiratory drug discovery and development company founded by
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