SOUTHAMPTON, United Kingdom,
Nov. 11, 2021 /PRNewswire/
-- Synairgen plc (LSE: SNG), the respiratory company
developing SNG001, a formulation for inhalation
containing the broad-spectrum anti-viral protein interferon beta
(IFN-beta) for the treatment of severe viral lung
infections, today announces that it has achieved its
recruitment target of 610 randomised patients for its global Phase
3 SPRINTER trial (SG018) evaluating SNG001 for the
treatment of hospitalised COVID-19 patients.
Synairgen's SG018 Phase 3 trial is a randomised,
double-blind, placebo-controlled study being conducted
in 17 countries. Once the final patients have completed
the initial 35-day trial period, quality assurance and statistical
analysis will be completed. Accordingly, as communicated
previously, top line data from the trial is expected in early 2022
and, conditional upon a successful Phase 3 readout, the Company is
preparing for the filing of an Emergency Use Authorisation (EUA) in
the US for patients requiring hospitalisation due to COVID-19.
Richard Marsden, CEO
of Synairgen, said: "Even with extensive
vaccine programmes, in the US alone, thousands of patients a day
are still being hospitalised due to serious COVID-19 symptoms.
Doctors have highlighted the urgent need for more treatment options
for these patients. We believe that SNG001, our investigational
inhaled formulation of interferon beta, a naturally-occurring,
broad-spectrum antiviral protein, could offer a compelling new
treatment option. With the trial having achieved its randomisation
target we look forward to announcing top line data early in
2022."
Tom
Wilkinson, Professor of Respiratory Medicine,
University of Southampton, and SPRINTER Trial Chief Investigator,
said: "Over the past year, based on a growing body of
clinical data, we have become even more confident that inhaled
interferon beta may have an important role in helping
hospitalised patients recover from COVID-19. Today's
milestone brings us one step closer to evaluating the potential of
SNG001 as an innovative, new therapy for hospitalised COVID-19
patients, something that is urgently needed."
Monica Kraft, Professor, Medicine Chair, Department of
Medicine, University of Arizona,
and SPRINTER Trial
Investigator, said: "Reaching full
recruitment across a global trial, with all the complexities that
COVID-19 has brought,
is a huge achievement. Finding effective
COVID-19 therapies still remains a pressing unmet need and I'm
therefore grateful to all the participants who have
been involved in this important trial. I look forward
to the readout of results in the near
future."
The recent graduation last month of SNG001 into Phase 3 of the
US National Institutes of Health-sponsored ACTIV-2 trial also
supports its potential in the non-hospital setting. SG018 has
been granted Fast Track status from the US Food and Drug
Administration (FDA) and was classified as an Urgent
Public Health study by the UK's National Institute for Health
Research (NIHR).
Synairgen will continue to work on the SPRINTER study with
Parexel Biotech, a division of the leading global clinical research
organisation, Parexel. Day 35 data will be reported in the first
instance followed by the long COVID results which will be collected
until Day 90.
IFN-beta is a naturally-occurring protein which
orchestrates the body's antiviral responses. It is a well-tolerated
drug and there is growing evidence that deficiency in IFN-beta
production in the lungs could put vulnerable patient groups at risk
of developing severe lower respiratory tract disease during
respiratory viral infections.
This announcement contains inside information for the
purposes of Article 7 of Regulation (EU) No. 596/2014
('MAR').
For further enquiries, please
contact:
Synairgen plc
Richard
Marsden, Chief Executive Officer
John Ward, Chief Financial
Officer
Brooke Clarke, Head of
Communications
Brooke.clarke@synairgen.com
Tel: + 44 (0) 23 8051 2800
finnCap (NOMAD and Joint
Broker)
Geoff Nash,
Kate Bannatyne, 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, Jessica Hodgson, Lucy Featherstone
synairgen@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 COVID-19 as
potentially the first host-targeted broad-spectrum antiviral
treatment delivered directly into the lungs. Granted Fast Track
status from the US Food and Drug Administration (FDA) and deemed an
Urgent Public Health study by the UK's National Institute for
Health Research (NIHR), Synairgen's Phase III clinical
programme is currently evaluating nebulised SNG001 in patients
across 17 countries. In a Phase II trial in hospitalised COVID-19
patients, SNG001 demonstrated a greater than twofold chance of
recovery to 'no limitation of activities' versus
placebo.1
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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https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30511-7/fulltext
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