RNS Number : 1488X
30 April 2021
('Synairgen' or the 'Company')
Synairgen announces data from Home Cohort of SG016 Phase II
trial of inhaled interferon beta in COVID-19 patients and
encouraging combined data for whole SG016 trial
- The vast majority of Home Cohort patients experienced mild
disease - only two patients were hospitalised during the treatment
period, both on placebo
- Home Cohort patients successfully self-administered SNG001
- The degree of breathlessness at start of treatment indicates
which patients should be treated with SNG001 both in hospital and
- Analysis of the combined data from the Hospital and Home
Cohorts showed that the more breathless patients are significantly
more likely (>3 fold) to recover on inhaled interferon beta
(SNG001) than placebo
- The study results reinforce confidence in ongoing Phase III
study, with data readout on track for H2 2021
- Synairgen management and scientists to hold a 30 minute
webcast with live Q&A at 9.00 BST today
Southampton, UK - 30 April 2021: Synairgen plc (LSE: SNG), the
respiratory company developing inhaled interferon beta (IFN-beta)
for the treatment of severe viral lung infections, today announces
results from the Home Cohort of its SG016 Phase II trial of SNG001
in SARS-CoV-2 infected patients and data from the combined analysis
of the Hospital and Home Cohorts.
SNG001 is a formulation containing IFN-beta for nebulisation,
allowing it to be delivered directly into patients' lungs. A number
of studies have reported that the SARS-CoV-2 virus suppresses
natural production of IFN-beta and prevents induction of anti-viral
responses by infected cells. Furthermore, some people have
deficiencies in antiviral IFN signalling that make them more
vulnerable to spread of the virus from the nose into the lungs
where it can cause severe breathing difficulties. These findings
provide a rationale to deliver IFN-beta directly to the surface
epithelial cells of the lungs, the primary site of virus infection
in the lungs, to prevent severe lower respiratory tract illness
caused by the SARS-CoV-2 virus.
The COVID-19 Phase II study (SG016)
Synairgen's placebo-controlled Phase II trial evaluated SNG001
for the prevention of severe lower respiratory tract (LRT) illness
caused by SARS-CoV-2, determined by evaluating change in condition
measured using the WHO Ordinal Scale for Clinical Improvement
(OSCI) during the dosing period (the primary endpoint). The SG016
trial involved 221 patients in two cohorts:
-- Hospital Cohort: 101 patients in the hospital setting, where
patients on SNG001, compared to placebo were twice as likely to
recover from severe LRT illness to the point where they had 'no
limitation of activities' (level 1 on the OSCI) without rebound,
and had reduced breathlessness.(1)
-- Home Cohort: 120 'at risk' (aged over 65 or over 50 with a
risk factor) patients in the home setting to investigate if SNG001
could prevent development of severe LRT illness.
Trial findings from Home Cohort
In total, only two patients were admitted to hospital during the
treatment period, both from the placebo group. The hospitalisation
rate (approximately 3% in the placebo group) in this 'at risk'
COVID-19 patient population was lower than had been originally
anticipated, but is in line with other recent large peer-reviewed
therapeutic studies. (2) Consequently, the prevention of severe LRT
illness could not be determined.
The majority of patients exhibited only mild disease which we
believe compromised the possibility of showing treatment effects in
the Home Cohort. We therefore decided to analyse the subset of
patients with most severe symptoms.
A post hoc analysis was conducted focusing on the 12% of
patients who had significant breathlessness (marked or severe, as
defined in Note a) at the time they began treatment. In these
patients, the recovery to level 1 on the OSCI ('no limitation of
activities') followed a similar pattern to that observed previously
in the hospital population where SNG001 accelerated recovery. This
led to an analysis of the impact of SNG001 across the Home and
Hospital Cohorts in breathless patients.
A further finding from the Home Cohort was that patients can
successfully initiate treatment "remotely ", self- administering
SNG001 at home without the need for a face-to-face meeting with a
health care professional, reducing the burden on hospital
facilities and minimising the risk of onward infection.
Overall analysis of SG016 trial, combining Hospital and Home
A combined analysis of the Hospital and Home Cohorts data was
conducted to explore the impact of the different levels of
breathlessness, which is one of the most prominent symptoms of
COVID-19, on time to recovery.
-- An assessment of placebo patients only indicated that those
with marked or severe breathlessness at time of treatment
initiation had slower recovery to no limitation of activities than
those patients who were not as breathless.
-- In the Hospital Cohort (reported in July 2020) patients were
2.19 times more likely to recover to level 1 on the Ordinal Scale
compared to placebo, HR 2.19, p=0.043. The addition of the 12
markedly and severely breathless Home Cohort patients changes the
Hazard Ratio to 2.49, p=0.009.
-- Interestingly, not all hospitalised patients were markedly or
severely breathless at time of treatment initiation. An analysis
including only patients who were markedly or severely breathless at
the time of treatment initiation, irrespective of whether they were
in hospital or at home, showed that those treated with SNG001
(n=33) were 3.41 times more likely to recover than those on placebo
(n=36) (HR 3.41 [95% confidence interval 1.47- 7.94], p=0.004).
Richard Marsden, CEO of Synairgen, said: "I am delighted by the
finding that SNG001 treatment led to a threefold likelihood of
recovery to 'no limitation of activities' in the markedly/severely
breathless population compared to those on placebo in the home and
hospital setting, and that further analyses reinforce our previous
findings. It increases our conviction in the approach we have taken
to conduct an international Phase III trial in hospitalised
patients requiring supplemental oxygen, which is scheduled to read
out in the second half of this year.
"As Governments around the world , such as India, look to how
future outbreaks and variants may be handled , our virus-agnostic
therapeutic could help to save lives, release pressure on the
world's healthcare systems , and thereby potentially mitigate the
need for economically costly lockdowns."
Professor Tom Wilkinson, Professor of Respiratory Medicine at
the University of Southampton, commented: "The SG016 COVID-19 trial
of inhaled interferon beta has been very successful. Although the
vast majority of non-hospitalised patients had very mild symptoms,
the effects of SNG001 on the small group of markedly and severely
breathless patients indicated who might be benefitting most from
SNG001. Assessment of breathlessness as a predictor of protracted
recovery in the combined Home and Hospital Cohorts showed us that
non-breathless patients have no need for the innate immune response
boost that interferon beta provides, whereas the patients who were
breathless derive strong benefit from SNG001. This tells us that we
should target SNG001 at COVID-19 patients with marked or severe
breathlessness where it has a potentially significant benefit."
Professor Nick Francis, Professor of Primary Care Research at
the University of Southampton, commented: "With the knowledge
gained from this trial, identifying patients likely to benefit from
SNG001 in primary care will be a relatively simple task, starting
with an assessment of breathlessness. In parallel with the Phase
III trial in the hospital setting, there is now an urgent need to
assess SNG001 in the non-hospital setting, focussing entirely on
breathless COVID-19 patients. I look forward to discussing with
primary care platform study teams around the world whether SNG001
can be included in their existing studies.
"As a GP, I recognise the potential importance of these
findings, especially for countries that are still struggling with
this disease at the moment, and for reducing the burden for
patients and the healthcare system in any future waves that may be
coming our way."
Synairgen plans to submit the findings for peer review at an
upcoming medical conference or publication.
Members of the management team and scientists at Synairgen will
hold a webcast for analysts, followed by a live Q&A, at 9:00
BST today. Please find a link to this webcast here.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No. 596/2014 ('MAR').
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. ' https://investor.regeneron.com/news-releases/news-release-details/phase-3-trial-shows-regen-covtm-casirivimab-imdevimab-antibody ' .
a. Breathlessness scoring system from the Breathlessness, Cough
and Sputum Scale (BCSS)
How much difficulty did you have breathing today?
0 = None - unaware of any difficulty
1 = Mild - noticeable when performing strenuous activity (e.g.
2 = Moderate - noticeable even when performing light activity
(e.g. bedmaking or carrying groceries)
3 = Marked - noticeable when washing or dressing
4 = Severe - almost constant, present even when resting
For further enquiries, please contact:
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
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
Mary-Jane Elliott, Jessica Hodgson, Olivia Manser
Tel: +44 (0) 20 3709 5700
MKC Strategies, LLC (US Media Relations)
Tel: +1 516 606 6545
Notes for Editors
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 Phase II trials, COVID-19 patients
with marked/severe breathlessness demonstrated a threefold chance
of recovery when treated with SNG001 versus placebo. For more
detailed information, please see the notes below.
Synairgen is quoted on AIM (LSE: SNG). For more information
about Synairgen, please see www.synairgen.com
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
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
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. SNG001 has the potential to address the urgent need for
antiviral therapies for COVID-19 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.
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. (
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(END) Dow Jones Newswires
April 30, 2021 02:00 ET (06:00 GMT)
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