TIDMSNG
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/
For further enquiries, please contact:
Synairgen plc
Brooke Clarke, Head of Communications
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
Tel: +44 (0) 20 3709 5700
MKC STRATEGIES, LLC (US Media Relations)
Mary Conway
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 .
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