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RNS Number : 6835M
Synairgen plc
25 January 2021
Press release
Synairgen plc
('Synairgen' or the 'Company')
Synairgen announces inclusion of its inhaled interferon beta
treatment in US NIH ACTIV-2 trial in COVID-19 outpatients
ACTIV partnership is funded by "Operation Warp Speed", led by
the US Government's Department of Health and Human Services and
designed to speed up the development of the most promising
treatments and vaccine candidates for COVID-19
Southampton, UK - 25 January 2021: Synairgen plc (LSE: SNG), the
respiratory drug discovery and development company, today announces
a clinical trial agreement to include its inhaled interferon
beta-1a treatment (SNG001) in the ACTIV-2/A5401 Phase II/III trial
in patients with COVID-19 not yet requiring hospitalisation. The
trial is sponsored by the US National Institute of Allergy and
Infectious Diseases (NIAID), part of the US National Institutes of
Health (NIH).
NIH's Accelerating COVID-19 Therapeutic Inventions and Vaccines
(ACTIV)
(https://www.nih.gov/research-training/medical-research-initiatives/activ)
is a public-private partnership to develop a coordinated research
strategy to speed up the development of the most promising
treatments and vaccine candidates for COVID-19. ACTIV-2 is a master
protocol designed for evaluating multiple investigational agents
compared to placebo in adults with mild-to-moderate COVID-19, not
requiring hospitalisation.
The Phase II/III ACTIV-2 study, led by the NIAID-funded AIDS
Clinical Trials Group (ACTG), is an adaptive, randomised, blinded,
placebo-controlled trial. The Phase II evaluation of SNG001 will
see the recruitment of up to a maximum of 220 participants across
US sites, in a home-based setting, split between SNG001 and
placebo, and a positive result enables progression into the Phase
III part of the study.
NIAID is the regulatory sponsor and holder of the
Investigational New Drug application to conduct the ACTIV-2 study,
which is funded by Operation Warp Speed, a partnership led by the
US Department of Health and Human Services through NIAID, to
investigate and coordinate the development, manufacturing, and
distribution of COVID-19 diagnostics, therapeutics and
vaccines.
Richard Marsden, CEO of Synairgen, said: "The inclusion of our
inhaled interferon beta-1a treatment in the US Government-funded
ACTIV-2 trial reflects the strong interest that our Phase II data
has generated and the Company's strong belief that this drug could
play a vital role in the treatment of COVID-19. As an inhaled
treatment, SNG001 offers ease of use that makes it possible for
patients to administer it conveniently at home, reducing the risk
of virus transmission during hospital visits and relieving the
major logistical strain on healthcare systems.
At-home treatments also have the potential to be taken much
earlier in the course of the illness, preventing the progression of
the virus in the lower respiratory tract and, in the scenario where
hospitals are at capacity, treating patients in the home setting
could be the only option. We hope to gain valuable data from this
trial, which will aid us in progressing approval of SNG001 as a
treatment for COVID-19."
In addition, Synairgen commenced dosing in an international 610
patient Phase III trial on 12 January 2021, assessing the efficacy
of inhaled interferon beta in hospitalised patients with
COVID-19.
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.
On 20 January 2021, Synairgen announced that it had completed
recruitment of 120 COVID-19 patients (over the age of 65, or those
over 50 with a comorbidity) in the home setting for its SG016
trial. Results from this study are expected in Q2 2021.
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