TIDMSNG
RNS Number : 5153L
Synairgen plc
13 January 2021
Press release
Synairgen plc
('Synairgen' or the 'Company')
Synairgen announces commencement of dosing in its international
Phase III study of inhaled interferon beta in hospitalised COVID-19
patients
Southampton, UK - 13 January 2021: Synairgen plc (LSE: SNG), the
respiratory drug discovery and development company, today announces
that the first patient has been dosed in the UK as part of its
global Phase III trial (SG018) evaluating Synairgen's inhaled
formulation of interferon beta-1a (SNG001), for the treatment of
hospitalised COVID-19 patients.
As previously announced, Synairgen has appointed Parexel
Biotech, a division of the leading global clinical research
organisation, Parexel, to help conduct the Phase III trial and
several UK sites have now been initiated, with further sites in the
US and the EU expected to follow. The trial is deemed an Urgent
Public Health study by the UK's National Institute for Health
Research (NIHR). In the US, SNG001 has been granted Fast Track
status from the US Food and Drug Administration (FDA). The Company
is seeking further equivalent prioritisations and support from
governments in participating countries.
Synairgen's SG018 trial is a randomised placebo-controlled study
being conducted in approximately 20 countries enrolling a total of
610 COVID-19 patients who require supplemental oxygen. After
reporting the results for the primary and key secondary endpoints
of the study, enrolled patients will continue to be assessed for
long-COVID-19 symptoms.
Richard Marsden, CEO of Synairgen, commented: "We need
treatments as well as vaccines to fight highly pathogenic viruses
such as SARS-CoV-2. Development of treatments like ours will remain
necessary in cases where vaccines are not effective, for those who
do not get vaccinated, and in case the virus mutates to the point
where vaccines become less effective. We believe this trial
presents an opportunity for a significant UK scientific
breakthrough and, if given the right support, our drug could
rapidly assist with the global crisis."
Synairgen is also running an ongoing Phase II trial of inhaled
interferon beta in non-hospitalised 'at risk' patients, (SG016),
that is progressing rapidly. For more information and to take part,
visit www.covidtrialathome.com .
This announcement contains inside information as contained in
Article 7 of the Market Abuse Regulation No. 596/2014 ('MAR').
-ENDS-
For further enquiries, please contact:
Synairgen plc
Richard Marsden, Chief Executive Officer
John Ward, Finance Director
Tel: + 44 (0) 23 8051 2800
finnCap (NOMAD and joint broker)
Geoff Nash, Kate Bannatyne, Charlie Beeson (Corporate
Finance)
Alice Lane, Manasa Patil (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, Olivia Manser, Carina Jurs
synairgen@consilium-comms.com
Tel: +44 (0) 20 3709 5700
Notes for Editors
About Synairgen
Synairgen is a clinical-stage respiratory drug discovery and
development company founded by University of Southampton Professors
Sir Stephen Holgate, Donna Davies and Ratko Djukanovic. Synairgen
is currently fully focused on progressing its inhaled interferon
beta broad spectrum antiviral drug as an effective treatment for
people suffering with COVID-19 infection.
Synairgen's differentiating human biology BioBank platform and
world-renowned international academic KOL network has broader
applicability for lung viral defence in other respiratory disorders
including asthma and COPD. Synairgen is quoted on AIM (LSE: SNG).
For more information about Synairgen, please see
www.synairgen.com
SNG001 (inhaled Interferon beta) applicability to COVID-19
Interferon beta ('IFN-beta') is a naturally-occurring protein,
which orchestrates the body's antiviral responses. It is used
widely in the treatment of multiple sclerosis and is a safe and
well tolerated drug. There is growing evidence that deficiency in
IFN-beta production by the lung could explain the enhanced
susceptibility in 'at-risk' patient groups to developing severe
lower respiratory tract (lung) disease during respiratory viral
infections. Furthermore, viruses, including coronaviruses such as
SARS-CoV-2, have evolved mechanisms which suppress endogenous
IFN-beta production, helping the virus to evade the innate immune
system. The addition of exogenous IFN-beta before or during viral
infection of lung cells in vitro either prevents or greatly reduces
viral replication, potentially reducing the severity of infection
and accelerating recovery. Synairgen's SNG001 is a formulation of
IFN-beta-1a for direct delivery to the lungs via nebulisation. It
is pH neutral, and is free of mannitol, arginine and human serum
albumin, making it suitable for inhaled delivery direct to the site
of action. Phase I and II trial data have shown that SNG001
activates lung antiviral defences as measured in sputum cells, and
that SNG001 has been well tolerated in approximately 280
asthma/COPD/COVID-19 patients to-date.
In July 2020, Synairgen announced the results of its Phase II
double-blind, placebo-controlled study of 101 randomised COVID-19
hospitalised patients, which showed that SNG001 given for 14 days
was associated with greater odds of improvement versus placebo on
the WHO Ordinal Scale for Clinical Improvement and more rapid
recovery to the point where patients were no longer limited in
their activity, with a greater proportion of patients recovering
during the 28-day study period.
The results were published in The Lancet Respiratory Medicine:
"Safety and efficacy of inhaled nebulised interferon beta-1a
(SNG001) for treatment of SARS-CoV-2 infection: a randomised,
double-blind, placebo-controlled, phase 2 trial". Monk, P D PhD, et
al., 12 November 2020, accessible here .
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END
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