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RNS Number : 9327Z
Synairgen plc
20 September 2022
Synairgen plc
('Synairgen' or the 'Company')
Synairgen to present 60 and 90-day Long COVID data from Phase 3
SPRINTER study in hospitalised COVID-19 patients at IDWeek 2022
-- Analysis of 60 and 90-day data from Phase 3 SPRINTER trial in
hospitalised COVID-19 patients showed that SNG001 reduced risk of
recognised Long COVID symptoms
-- Company to present full analysis of the data at IDWeek 2022 in October in Washington D.C.
Southampton, UK - 20 September 2022: Synairgen plc (LSE: SNG),
the respiratory company developing SNG001, an investigational
formulation for inhalation containing the broad-spectrum antiviral
protein interferon beta, today announces it will present its
positive findings from the analysis of data from 60 and 90-day
follow-up visits from the Phase 3 SPRINTER trial in patients
hospitalised with COVID-19 at IDWeek 2022 to be held 19-23 October
2022 in Washington, D.C.
The analysis shows that when compared to placebo, SNG001 reduced
the relative risk of recognised symptoms of Long COVID at day 60
and/or day 90:
COVID symptoms Placebo SNG001 Relative X2 Test
at Day 60 and/or Risk Reduction
Day 90 follow-up
visit
Y N Y N
---- ---- --- ----
Fatigue/ Malaise 43 140 27 151 35.4% p=0.045
---- ---- --- ---- ---------------- --------
Shortness of Breath
(Dyspnoea) 33 150 23 155 28.3% p=0.180
---- ---- --- ---- ---------------- --------
Loss of Smell and/or
Taste 16 167 6 172 61.4% p=0.033
---- ---- --- ---- ---------------- --------
The full analysis, including several patient-reported outcome
measures, which is ongoing, will be presented in October at IDWeek
2022 and submitted for publication in a peer-reviewed journal.
Professor Chris Brightling, NIHR Senior Investigator, Department
of Respiratory Sciences at the University of Leicester, said: "This
promising Long COVID data is very welcome in an area of enormous
clinical need. While it merits further investigation, it is
exciting to see that SNG001 may have a positive effect in reducing
some of the most recognised and problematic symptoms associated
with Long COVID which afflicts millions of people and for which
there are no current treatments."
Richard Marsden, CEO of Synairgen, commented: "The announcement
of this data from our 60 and 90-day follow-up in patients who
participated in the SPRINTER trial adds to our rationale of
supporting further development and investigation of SNG001 as a
broad-spectrum antiviral for severe respiratory infections. We look
forward to presenting the results at IDWeek in October."
SNG001 is not approved for use anywhere in the world.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No. 596/2014 ('MAR').
For further enquiries, please contact:
Synairgen plc
Brooke Clarke, Head of Communications
Media@synairgen.com
Tel: + 44 (0) 23 8051 2800
finnCap (NOMAD and Joint Broker)
Geoff Nash, Charlie Beeson (Corporate Finance)
Alice Lane, Sunil 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, Namrata Taak, Lucy Featherstone
cscsynairgen@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
About Synairgen
Synairgen is a UK-based respiratory company focused on drug
discovery, development and commercialisation. The Company's primary
focus is developing SNG001 (inhaled interferon beta) for the
treatment of severe viral lung infections, including COVID-19, as
potentially the first host-targeted, broad-spectrum antiviral
treatment delivered directly into the lungs. SNG001 has been
granted Fast Track status from the US Food and Drug Administration
(FDA). Founded by University of Southampton Professors Sir Stephen
Holgate, Donna Davies and Ratko Djukanovic in 2003, Synairgen is
quoted on AIM (LSE: SNG). For more information about Synairgen,
please see www.synairgen.com .
About SPRINTER (SG018) trial
The SPRINTER trial (SG018; NCT04732949) was a global Phase 3,
randomised, placebo-controlled, double-blind, clinical trial
assessing the efficacy and safety of inhaled SNG001 on top of
standard of care (SOC) for the treatment of adults hospitalised due
to COVID-19 requiring treatment with supplemental oxygen by mask or
nasal prongs. Patients requiring high-flow nasal oxygen therapy,
non-invasive ventilation, or endotracheal intubation (invasive
ventilation) at randomisation were excluded. COVID-19 was confirmed
using a validated molecular test for the presence of the SARS-CoV-2
virus.
Patients were randomised to receive SNG001 (N=314) or placebo
(N=309) once daily for 14 days, plus standard-of-care. Long-COVID
symptoms (checklist) were assessed as a secondary endpoint at
follow-up visits via telephone/video call on Day 60 and Day 90. The
PRO measures assessed were: General Anxiety Disorder 7
Questionnaire (GAD-7), Patient Health Questionnaire-9 (PHQ-9),
Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue
Scale and Brief Pain Inventory (Short Form).
About SNG001
SNG001 is a pH-neutral formulation of interferon-beta (IFN-beta)
for inhalation that is delivered directly into the lungs using a
mesh nebuliser, which the Company is developing as a potential
host-directed antiviral treatment for patients hospitalised with
severe viral lung infections, including COVID-19. SNG001 has broad
potential applicability for patients hospitalised with respiratory
symptoms due to viral infections such as SARS-CoV-2, complicated
influenza, RSV, adenovirus, para-influenza and rhinoviruses.
Viruses have been shown to suppress the production of IFN-beta,
a naturally occurring protein that orchestrates the body's
antiviral defences, with the aim of evading host immune responses.
By administering IFN-beta into the lungs, the aim is to correct
this deficiency, potentially switching back on the lungs' antiviral
pathways to clear the virus. SNG001 has been shown to demonstrate
potent in vitro antiviral activity against a broad range of viruses
including SARS-CoV-2 and Alpha, Beta, Gamma, Delta and Omicron
variants.
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