RCS - Synairgen plc - Synairgen to present at ATS 2022

SynairgenAnnouncement

05/04/2022 07:00

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RNS Number : 2313H  Synairgen plc  05 April 2022

 

Synairgen plc

('Synairgen' or the 'Company')

Synairgen to present further analysis of Phase 3 SPRINTER trial in
hospitalised patients with COVID-19 at the ATS 2022 International Conference

 

Southampton, UK - 5 April 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 that further analysis of its Phase 3 SPRINTER trial data will be
presented at the ATS 2022 International Conference, being held between 13-18
May 2022 in San Francisco, at the following two sessions:

·    The Clinical Trials Symposium on Monday 16 May 2022, 9:30-11:00am
(PDT).

·    Thematic Poster Session. C62. "Expanding Our Insight Into COVID-19"
on Tuesday 17 May 2022, 11:15-13:15pm (PDT).

o  P Monk et al. SPRINTER: A Randomized, Double-Blind, Placebo-Controlled,
Phase 3 Trial to Determine the Efficacy and Safety of Inhaled Interferon
Beta-1a (SNG001) for the Treatment of Patients Hospitalized Due to COVID-19
(NCT04732949).

The selection of SNG001 into the Clinical Trials Symposium session follows a
pre-evaluation of key results by an International Conference Committee. The
session is a platform for important trial results that are novel and represent
important new understanding.

The ATS 2022 International Conference presentations will comprise a more
extensive analysis of the topline results which were announced on 21 February
2022 and can be viewed on the Company's website.

The analysis of the trial data is ongoing, and the Company intends to present
results from its further analysis to assess the robustness of the initial
observation that showed a prevention of progression to severe disease and
death (36% reduction in the per protocol population) which, although not
statistically significant, the Company and its clinical advisers believe
merits further investigation.

The analysis will also include an assessment of the data in respect of
high-risk patient populations, such as the elderly and those with certain
co-morbidities.

The findings, when presented at ATS 2022, will also be made available on the
Company's website.

The full analysis of the Phase 3 SPRINTER trial data, including some new
sub-group analyses, will be submitted for publication in a peer-reviewed
journal.

The Company also announces today that it will issue its FY 2021 financial
results on 25 May 2022 and provide a general company update then.

For further information on the ATS International Conference visit:
https://conference.thoracic.org/ (https://conference.thoracic.org/)

For further enquiries, please contact:

Synairgen plc

Brooke Clarke, Head of Communications

Media@syairgen.com (mailto:Media@syairgen.com)

Tel: + 44 (0) 23 8051 2800

 

finnCap (NOMAD and Joint Broker)

Geoff Nash, Kate Bannatyne, 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, Jessica Hodgson, Namrata Taak

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

 

Notes for Editors

About SPRINTER (SG018) trial

The SPRINTER trial (SG018; NCT04732949) was a global Phase 3, randomised,
placebo-controlled, double-blind, multi-site clinical trial assessing the
efficacy and safety of inhaled SNG001 on top of standard of care 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.

The trial, which recruited 623 patients, had two primary endpoints, evaluated
using Cox proportional hazards modelling:

·   Time to hospital discharge through Day 28, defined by the OSCI score
of 2 or below, with no rebound (readmission) at subsequent assessments

·    Time to recovery to "no limitation of activities" through Day 28,
where recovery is defined as the OSCI score of 1 or below, with no rebound at
subsequent assessments

Key secondary endpoints, analysed using logistic regression, were:

·    Progression to severe disease or death, defined by the WHO OSCI
score of 5 or above within 35 days of first dose

·    Progression to intubation or death, defined by the WHO OSCI score of
6 or above within 35 days of first dose

·     Death within 35 days of first dose

Topline results can be viewed on the Synairgen website.

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,
currently being investigated as a potential host-directed antiviral treatment
for COVID-19 patients.

The SARS-CoV-2 virus has 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 COVID-19 and Alpha, Beta, Gamma, Delta and Omicron
variants.

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 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) and the Phase 3 SPRINTER trial was deemed an Urgent
Public Health study by the UK's National Institute for Health Research (NIHR).
The topline data from Synairgen's Phase 3 clinical programme evaluating SNG001
in patients across 17 countries was announced in February 2022 and detailed
analysis of the data is ongoing.

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) .

 

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