AstraZeneca commences Phase II Trial

RNS Number : 7095T

Synairgen plc

22 July 2015

 

PRESS RELEASE

22 July 2015

SYNAIRGEN PLC

("Synairgen" or "the Company")

AstraZeneca commences AZD9412 Phase II trial in severe asthma

Southampton, UK, 22 July 2015: Synairgen plc (LSE: SNG), the respiratory drug discovery and development company, is pleased to announce that AstraZeneca has commenced its Phase IIa study of AZD9412 (inhaled interferon beta, developed by Synairgen and formerly known as SNG001). The study population will comprise patients with severe asthma, building on the clinical data from Synairgen's exploratory Phase lla trial in moderate to severe asthma, which showed that difficult to treat asthma patients appeared to derive most benefit from therapy.

AZD9412, a novel, inhaled interferon beta, supports the immune system by correcting a deficiency which makes patients vulnerable to respiratory tract viral infections. The programme was out-licensed to AstraZeneca by Synairgen in June 2014 in a global deal worth up to $232 million plus tiered royalties. AstraZeneca is responsible for all development, regulatory and commercial activities and on-going costs associated with this programme. The licence agreement with AstraZeneca also provides the opportunity to expand the clinical programme into other pulmonary diseases, including COPD.

This placebo-controlled Phase IIa trial seeks to enroll 220 asthma patients from countries in both the Northern and Southern Hemispheres (to maximize the benefit of access to a 'continuous' cold season). The study population will be GINA Step 4/5 asthma patients (that is patients requiring treatment with medium-to-high dose inhaled corticosteroids and a second controller medication) who have a history of severe exacerbations caused by cold viruses. The primary endpoint for the trial is the number of severe exacerbations during the 14 day dosing period. Further details about the trial are given on www.clinicaltrials.gov .         

Richard Marsden, Chief Executive Officer of Synairgen, commented: "We are delighted with the progress of the AZD9412 Phase IIa clinical trial and AstraZeneca's commitment to this exciting programme. We look forward to seeing the results in early 2017."

ENDS

For further information, please contact:

Synairgen plc 

Richard Marsden, Chief Executive Officer

John Ward, Finance Director

Tel: + 44 (0) 23 8051 2800

finnCap

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 / Jessica Hodgson / Laura Thornton

[e-mail]

Tel: [phone]

Notes for Editors

About Synairgen 

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 vitro and 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 - validated in June 2014 by the SNG001 (now AZD9412) agreement formed with AstraZeneca. Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen and the interferon beta programme, please see www.synairgen.com.

 

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