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RNS Number : 0893J
Synairgen plc
18 December 2020
Press release
Synairgen plc
('Synairgen' or the 'Company')
COVID-19 Clinical Programme Update
- SNG001 given Fast Track designation and IND cleared by the US FDA
- Phase III trial design adapted which will expedite results
- Phase III trial to commence dosing in UK imminently
Southampton, UK - 18 December 2020: Synairgen plc (LSE: SNG),
the respiratory drug discovery and development company, today
announces updates to the Company's Phase III trial design
evaluating SNG001 as a treatment for patients with COVID-19 and
positive progress on the regulatory path.
Update to Phase III trial (SG018) protocol in COVID-19
patients
Following discussions with the regulatory agencies, the trial
has been amended as follows:
-- Removal of the lower dose arm, thereby reducing the number of
patients required to complete the placebo-controlled trial from 900
patients to 610 patients
-- Addition of a second primary endpoint. The primary endpoints
are now 'time to hospital discharge' and 'time to recovery'. The
primary assessment of efficacy will be supported by the key
secondary endpoint of 'progression to severe disease or death' and
other secondary endpoints. Both primary endpoints have at least 90%
power to detect a statistically significant effect of SNG001
compared to placebo
-- Addition of assessments for Long COVID-19 symptoms on day 60 and day 90
Initiation of the first SG018 sites has commenced in the UK,
with dosing expected to commence imminently. The SG018 trial was
deemed an Urgent Public Health study and recognised as a National
Priority by the National Institute for Health Research (NIHR) in
October 2020.
Investigational New Drug clearance and Expedited Regulatory
Pathway granted from the FDA
Synairgen's Investigational New Drug (IND) application to the
FDA to evaluate SNG001 as a treatment for patients with COVID-19,
has been cleared, enabling Synairgen to initiate its SG018 trial in
the US. Furthermore, the FDA has awarded SNG001 Fast Track status,
enhancing the ability of Synairgen to interact with the FDA and
shortening review timelines.
Update on the SG016 home trial in COVID-19 patients
This trial targets patients with a positive SARS-CoV-2 test
result who are aged over 65 and those over the age of 50 with 'high
risk' medical conditions. It is a trial designed to make it easy
and safe for trial participants and researchers to conduct the
research; all supplies for the trial are delivered directly to the
patient's door by courier, and all trial visits and assessments are
conducted virtually by video call. After a slow start in the
summer, recruitment and dosing are now progressing well with a
noticeable increase in the last two months. Those interested in
participating in the trial can visit www.covidtrialathome.com .
Richard Marsden, CEO of Synairgen, said: "With this adaptation
we should be able to reduce the time taken to complete the trial,
which, together with an expedited review from the FDA, could allow
us to get this therapy approved for patient use in COVID-19 more
rapidly. With trial sites now being set up, we anticipate dosing
the first patients imminently. SNG001(1) is one of the few
potential treatments to have shown efficacy against severe viral
lung infections such as COVID-19, and multiple approaches will be
needed to minimise the impact of this deadly virus.
"There remains a great need to develop breakthrough treatments
for patients who become ill with COVID-19, despite the recent
successes from the vaccine developers. This is especially important
if vaccine uptake is poor for any reason, or if any mutations in
the SARS-CoV-2 virus render the vaccines less effective."
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 .
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
Geoff Nash, Kate Bannatyne, 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 respiratory drug discovery and development
company founded by University of Southampton Professors Sir Stephen
Holgate, Donna Davies and Ratko Djukanovic. The business, focused
primarily on lung viral defence in asthma, COPD, and COVID-19, 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 https://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 or diabetes are
at greatest risk of developing severe or fatal disease.
Synairgen is currently recruiting into a trial of SNG001 in
COVID-19 patients (over the age of 65, or those over 50 with a
pre-existing medical condition) in the home setting. For more
information about the trial please visit www.covidtrialathome.com
.
Interferon beta applicability to COVID-19
Interferon beta ('IFN-beta') is a naturally-occurring protein,
which orchestrates the body's antiviral responses. 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. 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.
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