REG - Synairgen plc - Synairgen completes Phase III recruitment

SynairgenAnnouncement

11/11/2021 07:00

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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 (mailto:synairgen@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 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
(http://www.synairgen.com/) .

 

1 - https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30511-7/fulltex
(https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30511-7/fulltext)
t
(https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30511-7/fulltext)
 

 

 

 

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