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Synairgen plc
23 December 2022
Synairgen plc
('Synairgen' or the 'Company')
Results from SPRINTER Phase 3 trial published in the European
Respiratory Journal Open Research
Southampton, UK - 23 December 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 the online publication of
data from its Phase 3 SPRINTER trial in the peer reviewed European
Respiratory Journal Open Research (ERJOR) .
Topline results from this global, double-blind,
placebo-controlled trial were first shared in February 2022, with
the data analysis presented at the American Thoracic Society
International Conference in San Francisco in May 2022.
While the SPRINTER trial did not meet the primary endpoints of
discharge from the hospital and recovery, there was an encouraging
signal in reduction in the relative risk (RRR) of progression to
severe disease or death within 35 days (25.7% reduction in the
Intention-to-Treat population and 36.0% reduction in the Per
Protocol population). SNG001 was well tolerated as has been seen in
previous clinical trials.
The full title of the online publication is: "Nebulised
interferon beta-1a (SNG001) in hospitalised COVID-19: SPRINTER
Phase III Study" and can be accessed here .
Phillip Monk, CSO of Synairgen and Lead Author, said : "The
results from the SG016[1] Phase 2 and the SPRINTER trial of SNG001
in hospitalised patients, and the ACTIV-2 trial in the home setting
suggest that SNG001 may be preventing progression to severe
disease. With these data we remain confident in the potential of
SNG001 as a broad-spectrum antiviral for high-risk patient
populations infected with respiratory viruses including influenza
and RSV and are focused on its continued clinical development."
SNG001 is not approved for use anywhere in the world.
For further enquiries, please contact:
Synairgen plc
Brooke Clarke, Head of Communications
Media@synairgen.com
Tel: + 44 (0) 23 8051 2800
finnCap (NOMAD and Joint Broker)
Geoff Nash, Charlie Beeson (Corporate Finance)
Alice Lane, Sunil de Silva (ECM)
Tel: + 44 (0) 20 7220 0500
Numis Securities Limited (Joint Broker)
James Black, Freddie Barnfield, Duncan Monteith
Tel: + 44 (0) 20 7260 1000
Consilium Strategic Communications (Financial Media and Investor
Relations)
Mary-Jane Elliott, Namrata Taak, Lucy Featherstone
cscsynairgen@consilium-comms.com
Tel: +44 (0) 20 3709 5700
MKC STRATEGIES, LLC (US Media Relations)
Mary Conway
MConway@MKCStrategies.com
Tel: +1 516-606-6545
Notes for Editors
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 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.
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, influenza,
respiratory syncytial virus (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
at concentrations that are achievable following inhaled delivery of
SNG001 including RSV, rhinovirus, various influenza strains
including H5N1, MERS-CoV and SARS-CoV-2 including Alpha, Beta,
Gamma, Delta and Omicron variants of concern.
[1] Protocol No. SG016; NCT04385095
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