RNS Number : 2313H
05 April 2022
('Synairgen' or the 'Company')
Synairgen to present further analysis of Phase 3 SPRINTER trial in hospitalised patients with COVID-19 at the ATS 2022 International Conference
Southampton, UK - 5 April 2022: Synairgen plc (LSE: SNG), the respiratory company developing SNG001, an investigational formulation for inhalation containing the broad-spectrum antiviral protein interferon beta, today announces that further analysis of its Phase 3 SPRINTER trial data will be presented at the ATS 2022 International Conference, being held between 13-18 May 2022 in San Francisco, at the following two sessions:
· The Clinical Trials Symposium on Monday 16 May 2022, 9:30-11:00am (PDT).
· Thematic Poster Session. C62. "Expanding Our Insight Into COVID-19" on Tuesday 17 May 2022, 11:15-13:15pm (PDT).
o P Monk et al. SPRINTER: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Determine the Efficacy and Safety of Inhaled Interferon Beta-1a (SNG001) for the Treatment of Patients Hospitalized Due to COVID-19 (NCT04732949).
The selection of SNG001 into the Clinical Trials Symposium session follows a pre-evaluation of key results by an International Conference Committee. The session is a platform for important trial results that are novel and represent important new understanding.
The ATS 2022 International Conference presentations will comprise a more extensive analysis of the topline results which were announced on 21 February 2022 and can be viewed on the Company's website.
The analysis of the trial data is ongoing, and the Company intends to present results from its further analysis to assess the robustness of the initial observation that showed a prevention of progression to severe disease and death (36% reduction in the per protocol population) which, although not statistically significant, the Company and its clinical advisers believe merits further investigation.
The analysis will also include an assessment of the data in respect of high-risk patient populations, such as the elderly and those with certain co-morbidities.
The findings, when presented at ATS 2022, will also be made available on the Company's website.
The full analysis of the Phase 3 SPRINTER trial data, including some new sub-group analyses, will be submitted for publication in a peer-reviewed journal.
The Company also announces today that it will issue its FY 2021 financial results on 25 May 2022 and provide a general company update then.
For further information on the ATS International Conference visit: https://conference.thoracic.org/
For further enquiries, please contact:
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MKC STRATEGIES, LLC (US Media Relations)
Tel: +1 516-606-6545
Notes for Editors
About SPRINTER (SG018) trial
The SPRINTER trial (SG018; NCT04732949) was a global Phase 3, randomised, placebo-controlled, double-blind, multi-site clinical trial assessing the efficacy and safety of inhaled SNG001 on top of standard of care 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.
The trial, which recruited 623 patients, had two primary endpoints, evaluated using Cox proportional hazards modelling:
· Time to hospital discharge through Day 28, defined by the OSCI score of 2 or below, with no rebound (readmission) at subsequent assessments
· Time to recovery to "no limitation of activities" through Day 28, where recovery is defined as the OSCI score of 1 or below, with no rebound at subsequent assessments
Key secondary endpoints, analysed using logistic regression, were:
· Progression to severe disease or death, defined by the WHO OSCI score of 5 or above within 35 days of first dose
· Progression to intubation or death, defined by the WHO OSCI score of 6 or above within 35 days of first dose
· Death within 35 days of first dose
Topline results can be viewed on the Synairgen website.
SNG001 is a pH-neutral formulation of interferon-beta (IFN-beta) for inhalation that is delivered directly into the lungs using a mesh nebuliser, currently being investigated as a potential host-directed antiviral treatment for COVID-19 patients.
The SARS-CoV-2 virus has 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 COVID-19 and Alpha, Beta, Gamma, Delta and Omicron variants.
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 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) and the Phase 3 SPRINTER trial was deemed an Urgent Public Health study by the UK's National Institute for Health Research (NIHR). The topline data from Synairgen's Phase 3 clinical programme evaluating SNG001 in patients across 17 countries was announced in February 2022 and detailed analysis of the data is ongoing.
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.
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