TIDMSNG
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
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
Tel: +44 (0) 20 3709 5700
US Media:
Mary Conway
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 .
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