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Synairgen to start trial of SNG001 in COVID-19 imminentlyPress release Synairgen plc 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 Interferon beta (IFN-beta) potential applicability to COVID-19 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/key-action/Table_of_therapeutics_Appendix_17022020.pdf?ua=1). COVID-19 Clinical Trial Synairgen’s other current activities with COVID-19 Update on SNG001 Phase II trial in COPD 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 finnCap Consilium Strategic Communications (Financial Media and Investor Notes for Editors 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 |