Synairgen announces commencement of dosing in its international Phase III study of inhaled interferon beta in hospitalised COVID-19 patients

Synairgen announces commencement of dosing in its international Phase III study of inhaled interferon beta in hospitalised COVID-19 patients

Southampton, UK – 13 January 2021: Synairgen plc (LSE: SNG), the respiratory drug discovery and development company, today announces that the first patient has been dosed in the UK as part of its global Phase III trial (SG018) evaluating Synairgen’s inhaled formulation of interferon beta-1a (SNG001), for the treatment of hospitalised COVID-19 patients.

As previously announced, Synairgen has appointed Parexel Biotech, a division of the leading global clinical research organisation, Parexel, to help conduct the Phase III trial and several UK sites have now been initiated, with further sites in the US and the EU expected to follow. The trial is deemed an Urgent Public Health study by the UK’s National Institute for Health Research (NIHR). In the US, SNG001 has been granted Fast Track status from the US Food and Drug Administration (FDA).  The Company is seeking further equivalent prioritisations and support from governments in participating countries.

Synairgen’s SG018 trial is a randomised placebo-controlled study being conducted in approximately 20 countries enrolling a total of 610 COVID-19 patients who require supplemental oxygen. After reporting the results for the primary and key secondary endpoints of the study, enrolled patients will continue to be assessed for long-COVID-19 symptoms. 

Richard Marsden, CEO of Synairgen, commented: “We need treatments as well as vaccines to fight highly pathogenic viruses such as SARS-CoV-2. Development of treatments like ours will remain necessary in cases where vaccines are not effective, for those who do not get vaccinated, and in case the virus mutates to the point where vaccines become less effective. We believe this trial presents an opportunity for a significant UK scientific breakthrough and, if given the right support, our drug could rapidly assist with the global crisis.”

Synairgen is also running an ongoing Phase II trial of inhaled interferon beta in non-hospitalised ‘at risk’ patients, (SG016), that is progressing rapidly. For more information and to take part, visit www.covidtrialathome.com.

This announcement contains inside information as contained in Article 7 of the Market Abuse Regulation No. 596/2014 (‘MAR’).