REG - Synairgen plc - Synairgen Provides Update on ACTIV-2 Trial

SynairgenAnnouncement

17/03/2022 07:30

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RNS Number : 1126F  Synairgen plc  17 March 2022

Synairgen plc

('Synairgen' or the 'Company')

Synairgen Provides Update on ACTIV-2 Trial

 

Southampton, UK - 17 March 2022: Synairgen plc (LSE: SNG), the respiratory
company developing SNG001, a formulation for inhalation containing the
broad-spectrum antiviral protein interferon beta, today announces that the US
National Institute of Allergy and Infectious Diseases (NIAID), part of the
National Institutes of Health (NIH) has halted all patient recruitment in its
Phase 2/3 COVID-19 trial (Protocol ACTIV-2/A5401; "Adaptive Platform Treatment
Trial for Outpatients with COVID-19 (Adapt out COVID)"), which included the
assessment of SNG001.

The development today is due to the significant shift in the nature of the
pandemic which would necessitate a substantial modification of the study
design not feasible in this multiple treatment-arm, platform trial.

Due to these changes in the pandemic, a new clinical trial design is needed to
evaluate the efficacy of SNG001 against COVID-19. As a result, lead
investigators from ACTIV-2 and Synairgen are in ongoing discussions to try to
identify an appropriate clinical trial to continue the evaluation of SNG001.

The NIH led ACTIV-2 trial was established to investigate potential therapies
in non-hospitalised adults experiencing mild to moderate COVID-19. SNG001 was
included in this study in February 2021 and the Independent Data Safety
Monitoring Board for ACTIV-2 had previously (October 2021) recommended it
advance from Phase 2 into Phase 3.

Richard Marsden, CEO of Synairgen, commented: "Conducting clinical trials in
the time of COVID-19 is challenging but as important now as at the start of
the pandemic. Even with improved standard of care, there remains a critical
need to prevent progression to severe disease and death. As such, we are
actively seeking inclusion in platform trials for hospitalised patients and
are working closely with the NIH to also find a suitable trial for SNG001 in
home-based patients."

Synairgen expects to receive the Phase 2 data from ACTIV-2 in the first half
of this year and will evaluate it alongside the full dataset from its SPRINTER
trial to better understand the effects of SNG001 in patients at risk of
developing severe illness due to respiratory viruses.

SNG001 has demonstrated in vitro antiviral activity against a broad range of
respiratory viruses including SARS-CoV-2 and its variants including Delta and
Omicron. The recent topline data from the Phase 3 SPRINTER trial showed an
encouraging signal in reduction of progression to severe disease and death on
top of standard of care (36% relative risk reduction in the per protocol
population) which the Company is seeking to confirm in a large platform
trial.

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

Brooke Clarke

Media@syairgen.com (mailto:Media@syairgen.com)

info@synairgen.com

Tel: + 44 (0) 23 8051 2800

 

UK media and investors:

Consilium Strategic Communications

Mary-Jane Elliott/Jessica Hodgson

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

Tel: +44 (0) 20 3709 5700

 

US Media:

Mary Conway

MConway@MKCStrategies.com (mailto:MConway@MKCStrategies.com)

Tel: +1 516-606-6545

 

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

 

Notes for Editors

About ACTIV-2

Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) is a
public-private partnership led by the National Institutes of Health (NIH) and
coordinated by the Foundation for the National Institutes of Health (FNIH) to
develop a research strategy for prioritising and speeding development of the
most promising COVID-19 vaccines and treatments.

Further details can be found on:
https://www.nih.gov/research-training/medical-research-initiatives/activ

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,
currently being investigated as a potential host-directed antiviral treatment
for COVID-19 patients.

The SARS-CoV-2 virus has 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.

About Synairgen

Synairgen is a specialist respiratory biotechnology company whose primary
focus is developing its inhaled IFN-beta candidate (SNG001) for the treatment
of COVID-19 and other severe viral lung infections. SNG001 has been granted
Fast Track designation from the US Food and Drug Administration (FDA) and its
Phase 3 SPRINTER trial was deemed an Urgent Public Health study by the UK's
National Institute for Health Research (NIHR). 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/) .

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