Synairgen plc
('Synairgen' or the 'Company')
Synairgen to present 60 and 90-day Long COVID data from Phase 3 SPRINTER study in hospitalised COVID-19 patients at IDWeek 2022
· Analysis of 60 and 90-day data from Phase 3 SPRINTER trial in hospitalised COVID-19 patients showed that SNG001 reduced risk of recognised Long COVID symptoms
· Company to present full analysis of the data at IDWeek 2022 in October 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:
| COVID symptoms at Day 60 and/or Day 90 follow-up visit | Placebo | SNG001 | Relative Risk Reduction | X2 Test | ||
| Y | N | Y | N | |||
| Fatigue/ Malaise | 43 | 140 | 27 | 151 | 35.4% | p=0.045 |
| Shortness of Breath (Dyspnoea) | 33 | 150 | 23 | 155 | 28.3% | p=0.180 |
| Loss of Smell and/or Taste | 16 | 167 | 6 | 172 | 61.4% | p=0.033 |
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.
Professor Chris Brightling, NIHR Senior Investigator, Department of Respiratory Sciences at the University of Leicester, said: "This promising Long COVID data is very welcome in an area of enormous clinical need. While it merits further investigation, it is exciting to see that SNG001 may have a positive effect in reducing some of the most recognised and problematic symptoms associated with Long COVID which afflicts millions of people and for which there are no current treatments."
Richard Marsden, CEO of Synairgen, commented: "The announcement of this data from our 60 and 90-day follow-up in patients who participated in the SPRINTER trial adds to our rationale of supporting further development and investigation of SNG001 as a broad-spectrum antiviral for severe respiratory infections. We look forward to presenting the results at IDWeek in October."
SNG001 is not approved for use anywhere in the world.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No. 596/2014 ('MAR').
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Synairgen plc
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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.
About SPRINTER (SG018) trial
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).
About SNG001
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.
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