RCS - Synairgen plc - SPRINTER Trial Results Published

SynairgenAnnouncement

23/12/2022 11:45

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RNS Number : 9353K  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
(https://openres.ersjournals.com/content/early/2022/12/14/23120541.00605-2022)
.

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 (mailto: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 (mailto:cscsynairgen@consilium-comms.com)

Tel: +44 (0) 20 3709 5700

 

MKC STRATEGIES, LLC (US Media Relations)

Mary Conway

MConway@MKCStrategies.com (mailto: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
(https://clinicaltrials.gov/ct2/show/NCT04385095?term=SG016&draw=2&rank=1)

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