Synairgen Regulatory News (SNG)

Press release

Synairgen plc

('Synairgen' or the 'Company')

Synairgen welcomes DSMC review of Phase II clinical trial in patients with COPD

~ No safety concerns identified with SNG001 by the Data Safety Monitoring Committee (DSMC)

~ DSMC endorses a pre-planned broadening of patient inclusion criteria to allow patients with more severe COPD into Synairgen's clinical trial

Southampton, UK - 14 March 2019: Synairgen (LSE: SNG), the respiratory drug discovery and development company, today announces that the Data Safety Monitoring Committee (DSMC) has completed its planned safety review of Part 2 of the Phase II clinical trial of Synairgen's inhaled interferon-beta (IFN-beta) therapeutic candidate, SNG001, in patients with chronic obstructive pulmonary disease (COPD).

In its review, the DSMC did not identify any safety concerns for patients currently enrolled in Part 2 of the trial and has subsequently endorsed a pre-planned broadening of the patient inclusion criteria to allow patients with more severe COPD to participate in the trial.

Richard Marsden, Chief Executive Officer of Synairgen, said: "We welcome this decision from the DSMC, as it aids trial recruitment and enables us to dose patients who have a higher medical need. COPD exacerbations are the second most common cause of unplanned hospital admission in England, and we are pleased to have the opportunity to develop SNG001 to include these high-risk patients prior to potential hospitalisation."

- Ends -

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No. 596/2014 ("MAR").

For further enquiries, please contact:

Synairgen plc

Richard Marsden, Chief Executive Officer

John Ward, Finance Director

Tel: + 44 (0) 23 8051 2800

finnCap

Geoff Nash, Max Bullen-Smith (Corporate Finance)

Alice Lane (ECM)

Tel: + 44 (0) 20 7220 0500

Consilium Strategic Communications (Financial Media and Investor

Relations)

Mary-Jane Elliott, Sue Stuart, Olivia Manser

synairgen@consilium-comms.com

Tel: +44 (0) 20 3709 5701

Notes for Editors

About COPD 

COPD is a progressive lung disease punctuated by periods of exacerbation involving acute worsening of symptoms, which have major implications for both the patient and the healthcare system. COPD exacerbations are the second most common cause of unplanned hospitalisation in England.1 The risk that a cold will cause an exacerbation of COPD is around 50%2 with some identifiable sub-groups at higher risk than others3 (considerably higher than for asthmatic patients, where the risk that a cold will cause an exacerbation is less than 10%4). In the USA, the average cost of a hospitalisation following a visit to the Emergency Department for a COPD patient is $29,000.5

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.

Synairgen is currently conducting a two-part Phase II trial evaluating SNG001, the Company's inhaled interferon beta (IFN-beta) product. The Phase II trial, called SG015, has been designed to assess the safety of SNG001 in COPD patients and its clinical benefit in these patients when they have a cold or flu infection, a major driver of COPD exacerbations.

Core to Synairgen's business strategy is the realisation of value via licensing transactions. 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). In December 2017, the collaboration agreement was amended as Pharmaxis took on full responsibility for the programme, with Synairgen receiving a £5 million upfront payment and a share of at least 17% (net of allowable expenses) of any receipts from any onward licensing by Pharmaxis of the LOXL2 inhibitors in fibrotic indications.

Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen, please see www.synairgen.com 

References

1. Department of Health. An Outcomes Strategy for Chronic Obstructive Pulmonary Disease (COPD) and Asthma in England. Published July 2011

2. Johnston NW, et al. Colds as predictors of the onset and severity of COPD exacerbations International Journal of COPD 2017:12: 839-848

3. Wilkinson TMA, et al. A prospective, observational cohort study of the seasonal dynamics of airway pathogens in the aetiology of exacerbations in COPD Thorax 2017;0:1-9. Doi:10.1136/thoraxjnl=2016-209023

4. (i) Aviragen Therapeutics presentation Directing Next Generation Direct-Acting Antivirals May 2017. (ii) Synairgen analysis of INEXAS trial results, dated 27 September 2017 (https://www.synairgen.com/wp-content/uploads/2018/06/ifnb-press-release-final-26-sept-002.pdf)

5. Singh JA, et al. Utilization due to chronic obstructive pulmonary disease and its predictors: a study using the U.S. National Emergency Department Sample (NEDS). Respiratory Research 2016; 17:1