REG - Synairgen plc - SPRINTER Long COVID data presented at IDWeek

SynairgenAnnouncement

20/09/2022 07:00

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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 at Day 60 and/or Day 90 follow-up visit  Placebo     SNG001      Relative Risk Reduction  X2 Test
                                                         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 (mailto: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 (mailto:cscsynairgen@consilium-comms.com)

Tel: +44 (0) 20 3709 5700

 

MKC STRATEGIES, LLC (US Media Relations)

Mary Conway

MConway@MKCStrategies.com (mailto: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
(http://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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