27 April 2017
Synairgen plc - AZD9412 Update
Cold infections did not affect trial patients’ asthma in the INEXAS study as much as predicted, meaning that the drug’s effects on severe exacerbations could not be determined
Treatment with AZD9412 switched on antiviral responses in the lungs, improved morning peak flow (a measure of lung function), and was well tolerated
The study however, did not meet AstraZeneca’s predefined criteria for progression, and they have elected to return the rights to AZD9412 to Synairgen
Synairgen will conduct further analysis of the data and determine future development routes
Southampton, UK – 27th April 2017: Synairgen plc (LSE: SNG), the respiratory drug discovery and development company, today provides an update on AZD9412 (inhaled interferon beta).
In October 2016 Synairgen provided the market with an update on the INEXAS trial of AZD9412, a novel, inhaled interferon beta that supports the immune system by correcting a deficiency which makes patients vulnerable to respiratory tract viral infections (primarily common cold viruses). The trial was stopped early due to a low severe exacerbation event rate which compromised an assessment of this endpoint (number of severe exacerbations).
Treatment with inhaled interferon beta did however switch on the lungs’ antiviral defences (as measured by blood levels of the antiviral biomarker CXCL10), have a beneficial effect on lung function (Morning Peak Expiratory Flow: difference of 19.7 litres per minute average over the first 7 days of treatment (p=0.01)), and was well tolerated. Effects on biomarkers, lung function and the good tolerability profile were consistent with the Company’s own Phase II trial (SG005).
The study did not however meet AstraZeneca’s predefined criteria for progression, and they have elected to return the rights to AZD9412 to Synairgen.
Further analysis of samples from the trial is being completed by AstraZeneca. Data from this sample analysis and the clinical trial data will be licensed to Synairgen. Synairgen will complete the data analysis and will use this as a basis to determine the future direction of the programme.
“We believe that the biomarker, lung function and safety data from this and our previous study continue to support the potential of inhaled interferon beta as a treatment for vulnerable patients whose disease control is badly affected when they get a cold. We are particularly interested in the potential for COPD, where exacerbations are associated with disease progression and an increased risk of dying. Since we licensed this programme to AstraZeneca, the weight of data linking viruses to COPD exacerbations has increased, and the link of colds to secondary bacterial infections has become widely accepted.”
Professor Stephen Holgate CBEMedical Research Council Clinical Professor of Immunopharmacology at the University of Southampton
“We remain positive about the potential of inhaled interferon beta, particularly for patients with COPD who suffer due to respiratory viruses. Once we have completed the data analysis, we will provide an update on the programme and our plans for future development.”
CEO of SynairgenRichard Marsden
The information communicated in this announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014.
For further information, please contact:
Richard Marsden, Chief Executive Officer
John Ward, Finance Director
Tel: +44 (0) 23 8051 2800
Geoff Nash, James Thompson (Corporate Finance)
Stephen Norcross, Simon Johnson (Corporate Broking)
Tel: +44 (0) 20 7220 0500
Consilium Strategic Communications (Financial Media and Investor Relations)
Mary-Jane Elliott / Sue Stuart / Jessica Hodgson / Laura Thornton
Tel: +44 (0) 20 3709 5701
Synairgen is a respiratory drug discovery and development company founded by University of Southampton Professors Stephen Holgate, Donna Davies and Ratko Djukanovic. The business, focused primarily on asthma and COPD, uses its differentiating human biology BioBank platform and world-renowned international academic KOL network to discover and develop novel therapies for respiratory disease. Leveraging its scientific and clinical facilities at Southampton General Hospital, the Company uses in vitroand ex vivo models to progress opportunities into clinical development. The BioBank of human samples is used in these models to increase confidence in the likelihood of successful drug development. Core to Synairgen’s business strategy is the realisation of value via licensing transactions. This approach has been validated by the licensing agreement formed with AstraZeneca in June 2014 for Synairgen’s SNG001 (AZD9412) programme in asthma/COPD. In August 2015 the Company entered into a collaboration with Pharmaxis to develop an oral LOXL2 inhibitor to reduce fibrosis in patients with idiopathic pulmonary fibrosis (IPF). Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen, please see www.synairgen.com
Pharmaxis is an Australian research pharmaceutical company with a portfolio of products at various stages of development and approval. The company’s development pipeline is centred on its expertise in amine oxidase chemistry and includes Semicarbazide-Sensitive Amine Oxidase Inhibitors (SSAO) for Non-alcoholic Steatohepatitis (NASH) and inflammatory diseases including Chronic Obstructive Pulmonary Disease (COPD), and Lysyl Oxidase Inhibitors (LOX) targeting fibrotic diseases including pulmonary fibrosis and some cancers. Pharmaxis is listed on the Australian Securities Exchange (symbol PXS). For more information about Pharmaxis, please see www.pharmaxis.com.au.
About 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 had shown that common colds can cause severe exacerbations of asthma and that boosting the antiviral defences of the lung with AZD9412 (inhaled interferon beta, and antiviral protein) during this time could prevent exacerbations from developing.