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RNS Number : 2358M
Synairgen plc
20 January 2021
Press release
Synairgen plc
('Synairgen' or the 'Company')
Synairgen announces completion of recruitment into its Phase II
Home-Based COVID-19 study of inhaled interferon beta
- Establishing proof of concept for home administration
Southampton, UK - 20 January 2021: Synairgen plc (LSE: SNG), the
respiratory drug discovery and development company, is pleased to
announce that recruitment of 120 COVID-19 patients into its Phase
II trial evaluating inhaled formulation of interferon-beta-1a
(SNG001) conducted in the home setting has now been completed.
Results from the trial are expected in Q2 2021.
The COVID-19 Phase II Study (SG016)
Synairgen's two-part, placebo-controlled trial evaluating SNG001
as a treatment for COVID-19 infection involved dosing of (i) 101
patients in the hospital setting, the positive results from which
were published in The Lancet Respiratory Medicine in November
2020(1) , and (ii) 120 'at risk' patients in the home setting,
recruitment for which completed yesterday.
Innovative Virtual Trial Design for Home-Based Study
The study targeted patients with a positive SARS-CoV-2 test
result aged over 65, and those over the age of 50 with 'high risk'
medical conditions. The trial was designed to make it easy and safe
for trial participants and researchers to conduct the study; all
-supplies were delivered directly to the patient's door by a
courier, and all trial assessments were conducted remotely by study
doctors and nurses via video call. The study has confirmed the
feasibility of rapid roll-out of antiviral treatment in the context
of a pandemic, where there is a need to limit the movement of
people to minimise risks to patients, the public and healthcare
providers.
The trial was conducted in collaboration with the NIHR
Southampton Clinical Trials Unit and TranScrip Partners.
Richard Marsden, CEO of Synairgen, commented: "We are pleased to
have completed recruitment of 120 'at risk' patients into this
innovative placebo-controlled trial whereby all trial 'visits' were
conducted by video call. The trial is both a test of the drug, and
a test of how technology can be utilised to deliver and manage the
administration of an inhaled broad-spectrum antiviral to vulnerable
patients in the context of a pandemic, reducing the need to
transport infected patients, and eliminating virus exposure to
healthcare workers. We believe this methodology and treatments such
as SNG001 could be invaluable alongside vaccines, now and in the
future, to fight highly pathogenic viruses such as SARS-CoV-2. We
are extremely grateful to the team of healthcare workers,
pharmacists and logistics providers who have worked tirelessly to
deliver this trial which is a further example of great British
science, attracting interest from academia and governments around
the world."
Professor Nick Francis, Professor of General Practice at the
University of Southampton, commented: "We are delighted to announce
completion of recruitment into the SG016 Home trial. This is a
remarkable trial evaluating a novel therapeutic delivered in the
home setting to people with COVID-19 who are at risk of developing
complications. We have shown that inhaled therapies can be safely
delivered at home, without the need for the patients, nurses or
doctors to travel. Following the promising results from the SG016
Hospital Study, we are excited to see whether we can detect
important benefits from early use of inhaled interferon beta
(SNG001) for COVID-19 in the home environment, in terms of
resolution of symptoms, preventing hospitalisation, and reducing
the burden of Long-COVID."
Professor Gareth Griffiths, Professor of Clinical Trials and
Director of the NIHR Southampton Clinical Trials Unit, said: "We
were delighted to have supported Synairgen in running the
home-setting arm of the SG016 trial, and to use our expertise in
conducting clinical trials in a community setting. The innovative
trial design meant that patients with COVID-19 were able to take
part in the study from their own homes, with full support provided
by the trial team, and finding evidence for treatments in this
setting is a vital step forward in our fight against diseases such
as COVID-19."
In addition to The Lancet Respiratory Medicine publication,
there is a growing body of evidence to support use of interferon
beta in the context of COVID-19 infection as evidenced in the
recent publication in Nature Genetics, following research carried
out by the University of Southampton and published here .
References
1. 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 .
2. Nature Genetics: "A novel ACE2 isoform is expressed in human
respiratory epithelia and is upregulated in response to interferons
and RNA respiratory virus infection". 11 January 2021, accessible
here .
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 (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, Sue Stuart, 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 .
About Southampton Clinical Trials Unit
The Southampton Clinical Trials Unit (CTU) is a National
Institute for Health Research (NIHR) supported CTU with expertise
in the design, conduct and analysis of interventional clinical
trials. The CTU is based within the University of Southampton with
offices at the University Hospital Southampton NHS Foundation Trust
Southampton General Hospital site. (
www.southampton.ac.uk/ctu/index.page )
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