Synairgen plc

('Synairgen' or the 'Company')  

Synairgen announces its collaboration on the UNIVERSAL trial, an observational study of patients hospitalised due to a range of respiratory viruses

·      Led by the Clinical Trials Unit at the University of Southampton, supported by Synairgen and funded by Janssen

·      Will explore the varied nature of acute respiratory viral infections in hospitalised patients to inform the development of much-needed broad spectrum antiviral drugs

Southampton, UK - 5 September  2022: Synairgen plc (LSE: SNG), the respiratory company developing SNG001, an investigational formulation for inhalation containing the broad-spectrum antiviral protein interferon beta, today announces its collaboration on the UNIVERSAL trial, an observational study being led by the Clinical Trials Unit of the University of Southampton to explore and better understand the varied nature of acute respiratory viral infection and recovery seen in patients admitted to hospital with respiratory symptoms.

The Understanding Infection, Viral Exacerbation and Respiratory Symptoms at Admission-Longitudinal (UNIVERSAL) trial seeks to develop a prospective longitudinal clinical database of respiratory viral infections in hospitalised patients to inform the development of potential antivirals to treat severe viral lung infections caused by seasonal viruses and emerging viral threats. Patients admitted to hospital due to a range of different respiratory viruses will be sampled to determine the clinical and biological predictors of progression of disease, recovery and length of hospital stay. As an observational study, no treatments are being investigated.

The trial, which aims to recruit 1,000 patients, will be initiated at 10 sites across the UK following enrolment of its first patient which occurred on 1 September 2022. Viral testing equipment already owned by Synairgen and nursing staff at the Southampton clinical trial site are being provided by Synairgen, funding for the trial is being provided by Janssen.

Richard Marsden, CEO of Synairgen, commented: "The COVID-19 pandemic highlighted the important link between research and clinical care and its impact on the timely development of much-needed antivirals for severe lung viral infections caused by seasonal viruses and emerging respiratory viral threats. Our collaboration on the UNIVERSAL trial will help provide a better understanding of what could predict clinical outcomes in patients hospitalised with respiratory symptoms due to infection with a range of respiratory viruses. The UNIVERSAL trial will help to further inform the development programme of SNG001, our investigational broad-spectrum antiviral."

Prof. Tom Wilkinson, Lead investigator of the UNIVERSAL trial and Professor of Respiratory Medicine, University of Southampton, added: "As seen over the course of the pandemic, individual response to respiratory virus infection is variable from patient to patient, ranging from mild symptoms requiring no treatment to severe illness requiring higher levels of care. This observation highlights the need for a study like UNIVERSAL to better understand this patient journey to enable for the development of effective therapeutics for respiratory viral illness beyond COVID."

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Notes for Editors

About the UNIVERSAL trial

The Understanding Infection, Viral Exacerbation and Respiratory Symptoms at Admission-Longitudinal (UNIVERSAL) trial is an observational study led by the Clinical Trials Unit of the University of Southampton, supported by Synairgen and funded by Janssen, to explore the varied nature of acute respiratory viral infection and recovery seen in patients admitted to hospital with respiratory symptoms. The trial will be initiated across 10 sites in the UK and seek to enrol 1000 patients, where 1000 test positive for respiratory viral infection, over a 12-month period. The primary endpoints of the trial are to determine the incidence of different respiratory viruses in admitted, sampled patient population during the winter season and, the clinical and biological predictors of progression of disease, recovery and length of stay.

The trial will provide a better understanding of the natural history of acute respiratory viral infection and recovery to facilitate improved clinical management with the potential to identify options for intervention in those at risk of more severe disease.

About Synairgen

Synairgen is a UK-based respiratory company focused on drug discovery, development and commercialisation. The Company's primary focus is developing SNG001 (inhaled interferon beta) for the treatment of severe viral lung infections, including COVID-19, as potentially the first host-targeted, broad-spectrum antiviral treatment delivered directly into the lungs. SNG001 has been granted Fast Track status from the US Food and Drug Administration (FDA). Founded by University of Southampton Professors Sir Stephen Holgate, Donna Davies and Ratko Djukanovic in 2003, Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen, please see www.synairgen.com.