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RNS Number : 0247P
Synairgen plc
15 February 2021
Press release
Synairgen plc
('Synairgen' or the 'Company')
Synairgen announces that dosing has commenced with its inhaled
interferon beta product in US Government-funded NIH ACTIV-2 trial
in COVID-19 outpatients
Southampton, UK - 15 February 2021: Synairgen plc (LSE: SNG),
the respiratory drug discovery and development company, today
announces that dosing has begun in the inhaled interferon beta
formulation (SNG001) sub-study of the ACTIV-2 Phase II/III trial,
evaluating patients with mild to moderate COVID-19 symptoms not yet
requiring hospitalisation.
Richard Marsden, CEO of Synairgen, said: "We are delighted that
our inhaled interferon beta formulation has been entered into this
US Government-funded Phase II/III study and that dosing has now
commenced. With mutations of COVID-19 now emerging, and the concern
that mutations may render the vaccines less effective, the need for
broad spectrum treatment options remains very high. Our product is
a potentially effective treatment as it is a virus agnostic and, we
believe, strain agnostic antiviral, which is easy to use in the
hospital or home setting. We look forward to tracking the progress
of the ACTIV-2 trial alongside our other COVID-19 trials."
As announced by Synairgen on 25 January 2021, ACTIV is a
public-private partnership to develop a coordinated research
strategy to speed up the development of the most promising COVID-19
treatments and vaccines. ACTIV-2 is sponsored by the National
Institute of Allergy and Infectious Diseases (NIAID), one of the
National Institutes of Health, and is led by the NIAID-funded AIDS
Clinical Trials Group (ACTG).
If an investigational agent shows promise by demonstrating
safety and reducing COVD-19 symptoms through 28 days following
administration, the ACTIV-2 trial is designed to expand seamlessly
from a Phase II to a Phase III study to gather additional critical
data from a larger pool of volunteers without delay. Phase II
sub-studies enrol up to 220 volunteers, while exact enrolment size
of Phase III sub-studies will vary depending on mode of
administration of the investigational agent. The adaptive nature of
the ACTIV-2 trial allows for comparison of multiple interventions
with a shared group of placebo recipients. In addition to safety
and symptomatic efficacy signals, the sub-studies in ACTIV-2 assess
whether an investigational agent can reduce the amount of
SARS-CoV-2 virus detectable in the nasopharynx.
For more information on the ACTIV-2 study, please visit
www.riseabovecovid.org, or visit ClinicalTrials.gov and search
identifier NCT04518410.
Synairgen is also running an international 610 patient Phase III
trial, which is progressing well, assessing the efficacy of inhaled
interferon beta in hospitalised patients with COVID-19. The Company
also recently completed recruitment of a 120 'at-risk' COVID-19
patients study evaluating SNG001 as a treatment for use in the home
setting, results are expected on track in Q2 2021.
Information within this announcement is deemed by the Company to
constitute inside information under the Market Abuse Regulation
(EU) No. 596/2014.
For further enquiries, please contact:
Synairgen plc
Richard Marsden, Chief Executive Officer
John Ward, Finance Director
Tel: + 44 (0) 23 8051 2800
finnCap (Nominated Advisor & Joint Broker)
Geoff Nash, James Thompson, Charlie Beeson (Corporate
Finance)
Alice Lane, Sunila 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, Sue Stuart, Olivia Manser
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
beta1a 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
COVID-19
COVID-19, caused by the SARS-CoV-2 virus, is a global threat and
there is an urgent need to assess new treatments to prevent and
effectively treat the severe lower respiratory tract illness that
can occur with this disease. Older people and those with
co-morbidities such as heart and lung complications and diabetes
are at greatest risk of developing severe or fatal disease.
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 systemically for 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
especially SARS-CoV-2, have evolved multiple mechanisms for
suppressing endogenous IFN-beta production in the lung thereby
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
to reduce the severity of infection and accelerate recovery.
Recognising the importance of achieving high concentrations in the
lung where SARS-CoV-2 exerts most of its tissue damaging effects,
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 et al.,
12 November 2020, accessible here:
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30511-7/fulltext
.
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