Synairgen plc - Home trial recruitment completed

Press release

Synairgen plc

('Synairgen' or the 'Company')

Synairgen announces completion of recruitment into its Phase II Home-Based COVID-19 study of inhaled interferon beta

- Establishing proof of concept for home administration  

Southampton, UK - 20 January 2021: Synairgen plc (LSE: SNG), the respiratory drug discovery and development company, is pleased to announce that recruitment of 120 COVID-19 patients into its Phase II trial evaluating inhaled formulation of interferon-beta-1a (SNG001) conducted in the home setting has now been completed. Results from the trial are expected in Q2 2021.

The COVID-19 Phase II Study (SG016)

Synairgen's two-part, placebo-controlled trial evaluating SNG001 as a treatment for COVID-19 infection involved dosing of (i) 101 patients in the hospital setting, the positive results from which were published in The Lancet Respiratory Medicine in November 2020¹, and (ii) 120 'at risk' patients in the home setting, recruitment for which completed yesterday.

Innovative Virtual Trial Design for Home-Based Study

The study targeted patients with a positive SARS-CoV-2 test result aged over 65, and those over the age of 50 with 'high risk' medical conditions. The trial was designed to make it easy and safe for trial participants and researchers to conduct the study; all -supplies were delivered directly to the patient's door by a courier, and all trial assessments were conducted remotely by study doctors and nurses via video call. The study has confirmed the feasibility of rapid roll-out of antiviral treatment in the context of a pandemic, where there is a need to limit the movement of people to minimise risks to patients, the public and healthcare providers.

The trial was conducted in collaboration with the NIHR Southampton Clinical Trials Unit and TranScrip Partners.

Richard Marsden, CEO of Synairgen, commented: "We are pleased to have completed recruitment of 120 'at risk' patients into this innovative placebo-controlled trial whereby all trial 'visits' were conducted by video call. The trial is both a test of the drug, and a test of how technology can be utilised to deliver and manage the administration of an inhaled broad-spectrum antiviral to vulnerable patients in the context of a pandemic, reducing the need to transport infected patients, and eliminating virus exposure to healthcare workers. We believe this methodology and treatments such as SNG001 could be invaluable alongside vaccines, now and in the future, to fight highly pathogenic viruses such as SARS-CoV-2. We are extremely grateful to the team of healthcare workers, pharmacists and logistics providers who have worked tirelessly to deliver this trial which is a further example of great British science, attracting interest from academia and governments around the world."

Professor Nick Francis, Professor of General Practice at the University of Southampton, commented: "We are delighted to announce completion of recruitment into the SG016 Home trial. This is a remarkable trial evaluating a novel therapeutic delivered in the home setting to people with COVID-19 who are at risk of developing complications. We have shown that inhaled therapies can be safely delivered at home, without the need for the patients, nurses or doctors to travel. Following the promising results from the SG016 Hospital Study, we are excited to see whether we can detect important benefits from early use of inhaled interferon beta (SNG001) for COVID-19 in the home environment, in terms of resolution of symptoms, preventing hospitalisation, and reducing the burden of Long-COVID."

Professor Gareth Griffiths, Professor of Clinical Trials and Director of the NIHR Southampton Clinical Trials Unit, said: "We were delighted to have supported Synairgen in running the home-setting arm of the SG016 trial, and to use our expertise in conducting clinical trials in a community setting. The innovative trial design meant that patients with COVID-19 were able to take part in the study from their own homes, with full support provided by the trial team, and finding evidence for treatments in this setting is a vital step forward in our fight against diseases such as COVID-19."

In addition to The Lancet Respiratory Medicine publication, there is a growing body of evidence to support use of interferon beta in the context of COVID-19 infection as evidenced in the recent publication in Nature Genetics, following research carried out by the University of Southampton and published here.

References

1.   The Lancet Respiratory Medicine: "Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial". Monk, P D PhD, et al., 12 November 2020, accessible here.

2.   Nature Genetics: "A novel ACE2 isoform is expressed in human respiratory epithelia and is upregulated in response to interferons and RNA respiratory virus infection". 11 January 2021, accessible here.

Information within this announcement is deemed by the Company to constitute inside information under the Market Abuse Regulation (EU) No. 596/2014

For further enquiries, please contact:

Synairgen plc

Richard Marsden, Chief Executive Officer

John Ward, Finance Director

Tel: + 44 (0) 23 8051 2800

finnCap (NOMAD and Joint Broker)

Geoff Nash, Kate Bannatyne, Charlie Beeson (Corporate Finance)

Alice Lane, Manasa Patil (ECM)

Tel: + 44 (0) 20 7220 0500

Numis Securities Limited (Joint Broker)

James Black, Freddie Barnfield, Duncan Monteith

Tel: +44 (0) 20 7260 1000

Consilium Strategic Communications (Financial Media and Investor

Relations)

Mary-Jane Elliott, Sue Stuart, Olivia Manser, Carina Jurs

synairgen@consilium-comms.com

Tel: +44 (0) 20 3709 5700

Notes for Editors

About Synairgen 

Synairgen is a clinical-stage respiratory drug discovery and development company founded by University of Southampton Professors Sir Stephen Holgate, Donna Davies and Ratko Djukanovic. Synairgen is currently fully focused on progressing its inhaled interferon beta broad spectrum antiviral drug as an effective treatment for people suffering with COVID-19 infection. 

Synairgen's differentiating human biology BioBank platform and world-renowned international academic KOL network has broader applicability for lung viral defence in other respiratory disorders including asthma and COPD. Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen, please see www.synairgen.com

SNG001 (inhaled Interferon beta) applicability to COVID-19

Interferon beta ('IFN-beta') is a naturally-occurring protein, which orchestrates the body's antiviral responses. It is used widely in the treatment of multiple sclerosis and is a safe and well tolerated drug. There is growing evidence that deficiency in IFN-beta production by the lung could explain the enhanced susceptibility in '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, have evolved mechanisms which suppress endogenous IFN-beta production, helping the virus to evade the innate immune system. The addition of exogenous IFN-beta before or during viral infection of lung cells in vitro either prevents or greatly reduces viral replication, potentially reducing the severity of infection and accelerating recovery. 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. Phase I and II trial data have shown that SNG001 activates lung antiviral defences as measured in sputum cells, and that SNG001 has been well tolerated in approximately 280 asthma/COPD/COVID-19 patients to-date.

In July 2020, Synairgen announced the results of its Phase II double-blind, placebo-controlled study of 101 randomised COVID-19 hospitalised patients, which showed that SNG001 given for 14 days was associated with greater odds of improvement versus placebo on the WHO Ordinal Scale for Clinical Improvement and more rapid recovery to the point where patients were no longer limited in their activity, with a greater proportion of patients recovering during the 28-day study period.

The results were published in The Lancet Respiratory Medicine: "Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial". Monk, P D PhD, et al., 12 November 2020, accessible here.

About Southampton Clinical Trials Unit

The Southampton Clinical Trials Unit (CTU) is a National Institute for Health Research (NIHR) supported CTU with expertise in the design, conduct and analysis of interventional clinical trials. The CTU is based within the University of Southampton with offices at the University Hospital Southampton NHS Foundation Trust Southampton General Hospital site. (www.southampton.ac.uk/ctu/index.page)