TIDMSNG
Synairgen plc
24 May 2021
Press release
Synairgen plc
('Synairgen' or the 'Company')
Synairgen announces results of in vitro studies showing
antiviral activity of interferon beta against key SARS-CoV-2
variants
- SNG001 shows potent antiviral activity against SARS-CoV-2 variants
- Demonstrates broad-spectrum antiviral activity of
host-targeted antiviral treatment delivered directly into the
lungs
Southampton, UK - 24 May 2021: Synairgen plc (LSE: SNG), the
respiratory company developing an inhaled formulation of interferon
beta (SNG001) as a broad-spectrum antiviral for the treatment of
severe viral lung infections, currently in COVID-19 trials in the
hospital and community settings, today announces results from in
vitro studies showing the antiviral activity of SNG001 against two
SARS-CoV-2 variants.
Interferon beta ('IFN-beta') is a naturally-occurring protein,
which orchestrates the body's antiviral responses by triggering the
production of hundreds of antiviral proteins which act across the
viral replication cycle to confer broad-spectrum antiviral
activity. Nebulised SNG001 is delivered directly into patients'
lungs, the primary site of virus infection, to prevent severe lower
respiratory tract illness caused by the SARS-CoV-2 virus.
Since the first outbreak of COVID-19 in Wuhan, a number of
variants of SARS-CoV-2 have emerged that are spreading globally.(1)
Changes to the virus have the potential to make it more
transmissible or to enable the virus to evade the immune system,
prompting concerns that some vaccines and therapeutics developed to
prevent/treat COVID-19 may become less effective against certain
variants. So-called "variants of concern" such as the "Kent",
"South African" and "Indian" variants(2,3) have potential to halt
or slow the reopening of societies despite progress with
vaccination programmes. In the UK, alarm about the rapid growth of
the so-called "Indian" variant has led to speculation that
authorities may need to bring in renewed restrictions.
In vitro experiments were conducted at Viroclinics-DDL in the
Netherlands to confirm that SNG001 had activity against the B.1.1.7
("UK or "Kent") and B.1.351 ("South African") variants. In these
experiments, Vero E6 cells were treated with SNG001 prior to and
after infection with SARS-CoV-2. 16-24 hours after infection, the
presence of SARS-CoV-2 viral proteins was determined using an
immunostaining method. SNG001 potently reduced virus to
undetectable levels in cells infected with "Wuhan-like" (virus
strain: Germany/BavPat1/2020), the UK/Kent variant and the South
African variant. Concentrations, readily achievable following
inhaled delivery of interferon beta, that gave 90% inhibition
(IC(--) (90) ) were 3.2, 4.0 and 3.4 IU/mL respectively.
Prof. Sir Stephen Holgate CBE, Medical Research Council Clinical
Professor of
Immunopharmacology at the University of Southampton and
Co-Founder of Synairgen, said: "Emerging variants of SARS-CoV-2 are
of great concern as they may negatively impact on the effectiveness
of current vaccines and therapeutics. These data are not
surprising, and confirm the broad-spectrum antiviral activity of
SNG001, which has shown activity against a range of respiratory
viruses such as RSV, rhinovirus, adenovirus and influenza, and
reassuringly confirm its activity against these SARS-CoV-2 variants
which is important in the context of our ongoing Phase III trial in
hospitalised patients and the future use of this drug against
SARS-CoV-2 and other emerging viral threats."
Richard Marsden, CEO of Synairgen, added: "As expected, these
data confirm that SNG001 is a broad-spectrum antiviral product, now
also demonstrating applicability against SARS-CoV-2 variants. The
SARS-CoV-2 virus suppresses the production of the essential
antiviral protein IFN-beta to evade the host immune system; it is
therefore to be expected that when IFN-beta is reintroduced into an
infection experiment that the host cells are able to repel the
virus.
"Alongside vaccines, our lines of defence for this pandemic and
future outbreaks rely in part on access to effective antivirals
with broad-spectrum activity against a range of viruses and
variants. The current focus on the Indian variant demonstrates how
concerned Governments are about the risk that a variant may render
the vaccines less effective, and we are pleased to see initiatives
being put in place to accelerate and support development of
antiviral therapeutics as a backstop for patients who are admitted
to hospital. We are pleased to report that we will start dosing
patients at trial sites in India in our Phase III study
imminently."
Synairgen has previously shown the antiviral activity of SNG001
in cell-based assays against key respiratory viruses, including
rhinovirus, the most frequent cause of the common cold, RSV and
influenza, including pandemic H1N1 2009 and H5N1 'bird flu' strains
and SARS-CoV-2. SNG001 also showed broad-spectrum antiviral
activity in man with clinical efficacy seen in clinical studies
conducted in asthma and COPD patients with respiratory viral
infection caused by common cold (e.g. rhinovirus, RSV,
parainfluenza, adenoviruses, HMPV and seasonal coronaviruses) and
flu viruses.
References
1. Lauring AS, Hodcroft EB. Genetic Variants of SARS-CoV-2-What
Do They Mean? JAMA. 2021 Feb 9;325(6):529-531.
2. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-surveillance/variant-info.html
3.
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/986380/Variants_of_Concern_VOC_Technical_Briefing_11_England.pdf
For further enquiries, please contact:
Synairgen plc
Richard Marsden, Chief Executive Officer
John Ward, Chief Financial Officer
Tel: + 44 (0) 23 8051 2800
finnCap (NOMAD and Joint Broker)
Geoff Nash, Kate Bannatyne, Charlie Beeson (Corporate
Finance)
Alice Lane (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, Jessica Hodgson, Carina Jurs
synairgen@consilium-comms.com
Tel: +44 (0) 20 3709 5700
MKC Strategies, LLC (US Media Relations)
Mary Conway
MConway@MKCStrategies.com
Tel: +1 516 606 6545
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 focused on developing its product
candidate, SNG001 (inhaled interferon beta) for the treatment of
COVID-19. SNG001 is potentially the first host-targeted
broad-spectrum antiviral treatment delivered directly into the
lungs. The Company is evaluating nebulised SNG001 in its Phase III
clinical programme, which has been deemed an Urgent Public Health
study by the UK's National Institute for Health Research (NIHR).
SNG001 has also been granted Fast Track status from the US Food and
Drug Administration (FDA). In a Phase II trial, COVID-19 patients
with marked/severe breathlessness demonstrated a threefold greater
chance of recovery when treated with SNG001 versus placebo.
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 an ongoing global
pandemic and there is widespread recognition of the urgent need for
antiviral therapies, alongside vaccination programs, both for this
and future pandemics. Such therapies could be used to prevent and
effectively treat the severe lower respiratory tract illness that
can occur with these types of diseases.
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.
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 near to 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. SNG001 has the potential to address the urgent
need for antiviral therapies for COVID19 and for future pandemic
respiratory infections, alongside vaccination programmes.
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 (OSCI) 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 .
The Company's global Phase III trial (SG018) evaluating SNG001
for the treatment of hospitalised COVID-19 patients is ongoing. 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.
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