TIDMSNG
RNS Number : 4226T
Synairgen plc
20 July 2020
Press release
Synairgen plc
('Synairgen' or the 'Company')
Synairgen announces positive results from trial of SNG001 in
hospitalised COVID-19 patients
- Patients who received SNG001 had a 79% lower risk of
developing severe disease compared to placebo
- Patients who received SNG001 were more than twice as likely to
recover from COVID-19 as those on placebo
- A briefing for journalists will be held via webinar at 12:30 BST today
Southampton, UK - 20 July 2020: Synairgen plc (LSE: SNG), the
respiratory drug discovery and development company which originated
from research at the University of Southampton, is pleased to
announce positive results from its clinical trial of SNG001, its
wholly-owned inhaled formulation of interferon beta, in
hospitalised COVID-19 patients.
Richard Marsden, CEO of Synairgen, said: "We are all delighted
with the trial results announced today, which showed that SNG001
greatly reduced the number of hospitalised COVID-19 patients who
progressed from 'requiring oxygen' to 'requiring ventilation'. It
also showed that patients who received SNG001 were at least twice
as likely to recover to the point where their everyday activities
were not compromised through having been infected by SARS-CoV-2. In
addition, SNG001 has significantly reduced breathlessness, one of
the main symptoms of severe COVID-19. This assessment of SNG001 in
COVID-19 patients could signal a major breakthrough in the
treatment of hospitalised COVID-19 patients. Our efforts are now
focused on working with the regulators and other key groups to
progress this potential COVID-19 treatment as rapidly as
possible."
The double-blind placebo-controlled trial recruited 101 patients
from 9 specialist hospital sites in the UK during the period 30
March to 27 May 2020. Patient groups were evenly matched in terms
of average age (56.5 years for placebo and 57.8 years for SNG001),
comorbidities and average duration of COVID-19 symptoms prior to
enrolment (9.8 days for placebo and 9.6 days for SNG001).
Key findings:
The odds of developing severe disease (e.g. requiring
ventilation or resulting in death) during the treatment period (day
1 to day 16) were significantly reduced by 79% for patients
receiving SNG001 compared to patients who received placebo (OR 0.21
[95% CI 0.04-0.97]; p=0.046).
Patients who received SNG001 were more than twice as likely to
recover (defined as 'no limitation of activities' or 'no clinical
or virological evidence of infection') over the course of the
treatment period compared to those receiving placebo (HR 2.19 [95%
CI 1.03-4.69]; p=0.043).
Over the treatment period, the measure of breathlessness was
markedly reduced in patients who received SNG001 compared to those
receiving placebo (p=0.007).
Three subjects (6%) died after being randomised to placebo.
There were no deaths among subjects treated with SNG001.
In the patients with more severe disease at time of admission
(i.e. requiring treatment with supplemental oxygen), SNG001
treatment increased the likelihood of hospital discharge during the
study, although the difference was not statistically significant
(HR 1.72 [95% CI 0.91-3.25]; p=0.096). Median time to discharge was
6 days for patients treated with SNG001 and 9 days for those
receiving placebo. Furthermore, patients receiving SNG001 appeared
to be more than twice as likely to have recovered by the end of the
treatment period (HR 2.60 [95% CI 0.95-7.07]; p=0.062), although
this strong trend did not reach statistical significance. However
by day 28, patients receiving SNG001 treatment had statistically
significantly better odds of recovery (OR 3.86 [95% CI 1.27-11.75];
p=0.017).
Interestingly, the efficacy analyses indicate there is no
evidence of an association between the SNG001 positive treatment
effects and prior duration of COVID-19 symptoms.
Further analysis will be conducted over the coming weeks and
reported in due course.
Professor Tom Wilkinson, Professor of Respiratory Medicine at
the University of Southampton and Trial Chief Investigator,
commented: "We are delighted with the positive data produced from
this trial, which is the result of a momentous coordinated effort
from Synairgen, the University of Southampton, University Hospital
Southampton NHS Foundation Trust and the highly expert research
teams across the NIHR network and regulatory bodies in the UK. The
results confirm our belief that interferon beta, a widely known
drug that, by injection, has been approved for use in a number of
other indications, has huge potential as an inhaled drug to be able
to restore the lung's immune response, enhancing protection,
accelerating recovery and countering the impact of SARS-CoV-2
virus."
Professor Stephen Holgate CBE, Medical Research Council Clinical
Professor of Immunopharmacology at the University of Southampton
and Co-Founder of Synairgen, said: "Recognising that SARS-CoV-2 is
known to have evolved to evade the initial antiviral response of
the lung, our inhaled treatment of giving high local concentrations
of interferon beta, a naturally occurring antiviral protein,
restores the lung's ability to neutralise the virus, or any
mutation of the virus or co-infection with another respiratory
virus such as influenza or RSV, as could be encountered in the
winter if there is a resurgence of COVID-19."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No. 596/2014 ('MAR').
Media briefing at 12:30 BST today
A briefing for journalists , hosted by Richard Marsden,
Professor Tom Wilkinson and Professor Stephen Holgate, will be held
at 12:30 BST today. A link to the webinar can be found here
https://www.lsegissuerservices.com/spark/Synairgen/events/97cda0b9-0529-4be1-b1ca-471cc8dc1e94
and a conference call (for live Q&A) can be accessed via the
following dial-in details:
UK Participant Local Dial-In Number: 020 3107 0289
US Participant International US-Toll Dial-In Number: (918)
922-6506
Conference ID: 6328984
If you have any difficulties accessing the webinar or call,
please contact synairgen@consilium-comms.com .
The slides of the presentation will also be made available on
Synairgen's website at
https://www.synairgen.com/investors/presentations/ . A recording of
the call will be made available on Synairgen's website
www.synairgen.com for up to 30 days.
For further enquiries, please contact:
Synairgen plc
Richard Marsden, Chief Executive Officer
John Ward, Finance Director
Tel: + 44 (0) 23 8051 2800
finnCap
Geoff Nash, Kate Bannatyne, Charlie Beeson (Corporate
Finance)
Alice Lane, Manasa Patil (ECM)
Tel: + 44 (0) 20 7220 0500
Consilium Strategic Communications (Financial Media and
Investor
Relations)
Mary-Jane Elliott, Sue Stuart, Olivia Manser, Carina Jurs, Alex
Bridge
synairgen@consilium-comms.com
Tel: +44 (0) 20 3709 5700
Notes for Editors
About Synairgen
Synairgen is a respiratory drug discovery and development
company founded by University of Southampton Professors Stephen
Holgate, Donna Davies and Ratko Djukanovic. The business, focused
primarily on lung viral defence in asthma and COPD, uses its
differentiating human biology BioBank platform and world-renowned
international academic KOL network to discover and develop novel
therapies for respiratory disease. Synairgen is quoted on AIM (LSE:
SNG). For more information about Synairgen, please see
www.synairgen.com
The COVID-19 study
Synairgen's clinical trial in COVID-19 patients (SG016) is a
double-blind, placebo-controlled trial. The 220 patient trial
comprised 100 patients initiated in hospital and 120 patients to be
initiated in the home setting. The patients participating in the
hospital setting , which completed recruitment in May, have been
recruited across a number of NHS trusts and the trial has been
adopted by the NIHR Respiratory Translational Research
Collaboration which is comprised of leading centres in respiratory
medicine in the UK whose internationally recognised experts are
working together to accelerate development and discovery for
COVID-19.
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 or diabetes are
at greatest risk of developing severe or fatal disease.
Interferon beta (IFN-beta) potential applicability to
COVID-19
Interferon beta is a naturally occurring protein, which
orchestrates the body's antiviral responses. There is 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 and MERS-CoV, have evolved mechanisms which
suppress endogenous IFN-beta production, thereby helping the virus
evade the innate immune system. The addition of exogenous IFN-beta
before or during viral infection of lung cells either prevents or
greatly diminishes cell damage and viral replication, respectively.
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.
Two Phase II clinical trials in asthma showed that inhaled
SNG001 treatment activated antiviral pathways in the lung, along
with improving lung function in patients with a respiratory viral
infection.
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contact rns@lseg.com or visit www.rns.com.
END
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