TIDMSNG
RNS Number : 0219S
Synairgen plc
11 November 2021
Press Release
Synairgen plc
('Synairgen' or the 'Company')
Synairgen completes recruitment in its international Phase 3
SPRINTER study of SNG001 in hospitalised COVID-19 patients
-- Target of 610 patients from 17 countries achieved
-- Synairgen remains on track for top line results early in 2022
Southampton, UK - 11 November 2021: 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 .
1 - https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30511-7/fulltex t
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