Data from SG016 Phase II Clinical Trial published in Lancet Respiratory Medicine

Data from SG016 Phase II Clinical Trial published in Lancet Respiratory Medicine

• Data published in the peer-reviewed journal shows positive results for SNG001 in hospitalised COVID-19 patients

Southampton, UK – 13 November 2020: Synairgen plc (LSE: SNG), the respiratory drug discovery and development company, today announces the publication of data from the Company’s SG016 trial in The Lancet Respiratory Medicine journal. The SG016 trial randomised 101 hospitalised COVID-19 patients to either SNG001, Synairgen’s inhaled formulation of interferon beta-1a, or placebo. Positive topline results from the trial were originally announced on 20 July 2020, with more detailed results of primary endpoint analyses disclosed in the Company's 2020 Interim Results on 29 September 2020.

The double-blind, randomised, placebo-controlled trial assessed the efficacy and safety of inhaled SNG001 as a therapy for patients hospitalised with COVID-19. Patients were randomised (1:1) to receive SNG001 or placebo by inhalation via a mouthpiece once daily for 14 days. The primary endpoint was the change in clinical condition using the WHO Ordinal Scale for Clinical Improvement (OSCI) during the dosing period in the intention-to-treat population (ITT).

SNG001 was shown to be well tolerated and patients who received the drug had greater odds of improvement and recovered more rapidly. Patients receiving SNG001 had greater odds of improvement across the OSCI scale (OR 2·32; 95% CI: 1·07, 5·04; p=0·033) and were more likely to recover to “no limitation of activity” during treatment (HR 2·19; 95% CI: 1·03, 4·69; p=0·043). There were three deaths in the placebo group and none in the SNG001 group.

The full title of the publication is: "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”, and can be accessed here.

Professor Tom Wilkinson, Professor of Respiratory Medicine at the University of Southampton and Lead Author, said: “The results confirm our belief that interferon beta, a widely known drug approved for use in its injectable form for other indications, may have the potential as an inhaled drug to restore the lung’s immune response and accelerate recovery from COVID-19. This pH neutral, inhaled interferon beta-1a formulation (SNG001) provides high, local concentrations of the immune protein which boosts lung defences rather than targeting specific viral mechanisms. This might carry additional advantages of treating COVID-19 when it occurs alongside infection by another respiratory virus such as influenza or Respiratory Syncytial Virus that may well be encountered in the winter months.”

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