('Synairgen' or the 'Company')
Synairgen provides update on ACTIV-2 Trial
Southampton, UK - 17 March 2022: Synairgen plc (LSE: SNG), the respiratory company developing SNG001, a formulation for inhalation containing the broad-spectrum antiviral protein interferon beta, today announces that the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) has halted all patient recruitment in its Phase 2/3 COVID-19 trial (Protocol ACTIV-2/A5401; "Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt out COVID)"), which included the assessment of SNG001.
The development today is due to the significant shift in the nature of the pandemic which would necessitate a substantial modification of the study design not feasible in this multiple treatment-arm, platform trial.
Due to these changes in the pandemic, a new clinical trial design is needed to evaluate the efficacy of SNG001 against COVID-19. As a result, lead investigators from ACTIV-2 and Synairgen are in ongoing discussions to try to identify an appropriate clinical trial to continue the evaluation of SNG001.
The NIH led ACTIV-2 trial was established to investigate potential therapies in non-hospitalised adults experiencing mild to moderate COVID-19. SNG001 was included in this study in February 2021 and the Independent Data Safety Monitoring Board for ACTIV-2 had previously (October 2021) recommended it advance from Phase 2 into Phase 3.
Richard Marsden, CEO of Synairgen, commented: "Conducting clinical trials in the time of COVID-19 is challenging but as important now as at the start of the pandemic. Even with improved standard of care, there remains a critical need to prevent progression to severe disease and death. As such, we are actively seeking inclusion in platform trials for hospitalised patients and are working closely with the NIH to also find a suitable trial for SNG001 in home-based patients."
Synairgen expects to receive the Phase 2 data from ACTIV-2 in the first half of this year and will evaluate it alongside the full dataset from its SPRINTER trial to better understand the effects of SNG001 in patients at risk of developing severe illness due to respiratory viruses.
SNG001 has demonstrated in vitro antiviral activity against a broad range of respiratory viruses including SARS-CoV-2 and its variants including Delta and Omicron. The recent topline data from the Phase 3 SPRINTER trial showed an encouraging signal in reduction of progression to severe disease and death on top of standard of care (36% relative risk reduction in the per protocol population) which the Company is seeking to confirm in a large platform trial.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No. 596/2014 ('MAR').
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Notes for Editors
Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) is a public-private partnership led by the National Institutes of Health (NIH) and coordinated by the Foundation for the National Institutes of Health (FNIH) to develop a research strategy for prioritising and speeding development of the most promising COVID-19 vaccines and treatments.
Further details can be found on: https://www.nih.gov/research-t...
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.
Synairgen is a specialist respiratory biotechnology company whose primary focus is developing its inhaled IFN-beta candidate (SNG001) for the treatment of COVID-19 and other severe viral lung infections. SNG001 has been granted Fast Track designation from the US Food and Drug Administration (FDA) and its Phase 3 SPRINTER trial was deemed an Urgent Public Health study by the UK's National Institute for Health Research (NIHR). 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.