Synairgen to start trial of SNG001 in COVID-19 imminently

Southampton, UK – 18 March 2020: Synairgen plc (LSE: SNG), the respiratory drug

discovery and development company, today announces that it has received expedited

approvals from the Medicines and Healthcare products Regulatory Agency (MHRA)

and Health Research Authority (HRA) to conduct a trial of SNG001 (inhaled formulation

of interferon-beta-1a) in COVID-19 patients to potentially assist with the global

outbreak of the virus.

COVID-19, caused by the SARS-CoV-2 virus, is a global threat and there is an urgent

need to assess new treatments to prevent and effectively treat the severe lower

respiratory tract illness that can occur with this disease. Older people and those with

co-morbidities such as heart and lung complications or diabetes are at greatest risk of

developing severe or fatal disease.

Interferon beta (IFN-beta) potential applicability to COVID-19

Interferon beta is a naturally occurring protein, which orchestrates the body’s antiviral

responses. There is evidence that deficiency in IFN-beta production by the lung could

explain the enhanced susceptibility of these at-risk patient groups to developing severe

lower respiratory tract (lung) disease during respiratory viral infections. Furthermore,

viruses, including coronaviruses such as SARS-CoV-2 and MERS-CoV, have evolved

mechanisms which suppress endogenous IFN-beta production, thereby helping the

virus evade the innate immune system. The addition of exogenous IFN-beta before or

during viral infection of lung cells either prevents or greatly diminishes cell damage and

viral replication, respectively. Synairgen’s SNG001 is a formulation of IFN-beta-1a for

direct delivery to the lungs via nebulisation. It is pH neutral, and is free of mannitol,

arginine and human serum albumin, making it suitable for inhaled delivery direct to the

site of action.

SNG001 could prove to have an important role to play in outbreaks such as the current

COVID-19 epidemic, particularly in respect of the population at highest risk of being

severely affected by this and similar viruses.

SNG001 was identified in the WHO’s Landscape analysis of therapeutics as at 17

February 2020 as the only Phase 2/Phase 3/Observational therapy delivered by the

inhaled route (https://www.who.int/blueprint/priority-diseases/keyaction/Table_of_therapeutics_Appendix_17022020.pdf?ua=1).

Two Phase II clinical trials in asthma showed that inhaled SNG001 treatment activated

antiviral pathways in the lung along with improving lung function in patients with a

respiratory viral infection. We have also shown that treatment with inhaled SNG001

reduced lung viral load and lung pathology in an in vivo swine flu driven model of viral

pneumonia. At the time of the MERS-CoV outbreak in 2013, Synairgen collaborated

with the National Institutes of Health (NIH) in the US to show that SNG001 could protect

against MERS-CoV infection of lung cells in vitro.

COVID-19 Clinical Trial

Synairgen’s Phase II trial in COVID-19 patients (SG016) will be a double-blind,

placebo-controlled trial. Initially, the pilot phase of the study will involve 100 COVID-19

patients, will take place across a number of NHS trusts and has been adopted by the

NIHR Respiratory Translational Research Collaboration which is comprised of leading

centres in respiratory medicine in the UK whose internationally recognised experts are

working together to accelerate development and discovery for COVID-19. A successful 

outcome from the pilot phase will inform onwards progression of SNG001 in COVID19 patients. The trial is expected to commence imminently.

Synairgen’s other current activities with COVID-19

Since the outbreak of COVID-19, Synairgen has been approached by, and is in

discussion with, a number of other medical, scientific, and Governmental bodies (both

in the UK, US and internationally) seeking to investigate novel therapeutics in this area.

Update on SNG001 Phase II trial in COPD

Synairgen is now close to completing a Phase II study in chronic obstructive pulmonary

disease (COPD) patients with confirmed respiratory viral infections and pre-existing

significant impairment of lung function. With 109 out of a target 120 participants already

dosed, this trial has been paused to minimise the chance of vulnerable patients being

exposed to further infection risk and to minimise distraction for respiratory staff in the

UK hospitals and GP sites conducting the trial, who will be at the forefront in dealing

with patients suffering from COVID-19. We are currently exploring ways to adapt the

trial to enable patients in the pre-treatment pool to be dosed if they become infected

with SARS-CoV-2.

Early data from this double-blind, placebo-controlled trial have demonstrated that the

antiviral responses in the lung (assessed using sputum biomarkers) are similar to those

observed in the asthma trial, where we saw clinical benefit in lung function.

Richard Marsden, CEO of Synairgen, commented: “We have worked intensively

with the relevant authorities and collaborators to enable SNG001 to be assessed in

COVID-19 patients. SNG001 has been well tolerated in clinical trials in over 200

respiratory patients to date and has accelerated lung function recovery in two Phase II

asthma trials in patients with a cold or flu infection. A successful outcome from this trial

in COVID-19 patients would be a major breakthrough in the fight against this

coronavirus pandemic.”

Professor Tom Wilkinson, Professor of Respiratory Medicine at the University of

Southampton and Trial Chief Investigator, commented: “We are facing an

unprecedented health challenge with COVID-19 which desperately requires the rapid

development of new therapeutic strategies. There are a limited number of candidate

new treatments available and so it is vital we can rapidly generate high quality evidence

on the role of these in COVID-19 patients. The UK research delivery and regulatory

teams have worked incredibly effectively to enable this world leading trial to achieve

approvals so rapidly which has enabled our motivated and highly expert team of

researchers to get this vital study running straight away.”

Professor Stephen Holgate, Medical Research Council (MRC) Professor of

Immunopharmacology, commented: “The reduced innate immune response that

exists in the lung of those at most risk of serious COVID-19 disease such as older

people and those with pre-existing lung disease makes such patients ideal candidates

to receive inhaled SNG001 to replace their interferon deficiency. This is especially so

because SARS-CoV-2, along with MERS-CoV and SARS-CoV, is equipped to evade

this first line of viral defence. In the absence of a suitable vaccine, increasing the host’s

own immunity to enhance protection and virus elimination would seem a logical

therapeutic approach.”

This announcement contains inside information as defined in Article 7 of the Market Abuse

Regulation 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, Kate Bannatyne, Charlie Beeson (Corporate Finance)

Alice Lane, Manasa Patil (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 5700

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 lung viral defence in 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.

Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen,

please see www.synairgen.com