Synairgen plc announced it will present its positive findings from the analysis of data from 60 and 90-day follow-up visits from the Phase 3 SPRINTER trial in patients hospitalised with COVID-19 at IDWeek 2022 to be held 19-23 October 2022 in Washington, D.C. The analysis shows that when compared to placebo, SNG001 reduced the relative risk of recognised symptoms of Long COVID at day 60 and/or day 90: The full analysis, including several patient-reported outcome measures, which is ongoing, will be presented in October at IDWeek 2022 and submitted for publication in a peer-reviewed journal. SNG001 is not approved for use anywhere in the world. The SPRINTER trial (SG018; NCT04732949) was a global Phase 3, randomised, placebo-controlled, double-blind, clinical trial assessing the efficacy and safety of inhaled SNG001 on top of standard of care (SOC) for the treatment of adults hospitalised due to COVID-19 requiring treatment with supplemental oxygen by mask or nasal prongs.

Patients requiring high-flow nasal oxygen therapy, non-invasive ventilation, or endotracheal intubation (invasive ventilation) at randomisation were excluded. COVID-19 was confirmed using a validated molecular test for the presence of the SARS-CoV-2 virus. Patients were randomised to receive SNG001 (N=314) or placebo (N=309) once daily for 14 days, plus standard-of-care.

Long-COVID symptoms (checklist) were assessed as a secondary endpoint at follow-up visits via telephone/video call on Day 60 and Day 90. The PRO measures assessed were: General Anxiety Disorder 7 Questionnaire (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale and Brief Pain Inventory (Short Form). SNG001 is a pH-neutral formulation of interferon-beta (IFN-beta) for inhalation that is delivered directly into the lungs using a mesh nebuliser, which the Company is developing as a potential host-directed antiviral treatment for patients hospitalised with severe viral lung infections, including COVID-19.

SNG001 has broad potential applicability for patients hospitalised with respiratory symptoms due to viral infections such as SARS-CoV-2, complicated influenza, RSV, adenovirus, para-influenza and rhinoviruses. Viruses have been shown to suppress the production of IFN-beta, a naturally occurring protein that orchestrates the body's antiviral defences, with the aim of evading host immune responses. By administering IFN-beta into the lungs, the aim is to correct this deficiency, potentially switching back on the lungs' antiviral pathways to clear the virus.

SNG001 has been shown to demonstrate potent in vitro antiviral activity against a broad range of viruses including SARS-CoV-2 and Alpha, Beta, Gamma, Delta and Omicron variants.