Synairgen plc Update on SNG001 (4606D)
March 03 2022 - 2:00AM
UK Regulatory
TIDMSNG
RNS Number : 4606D
Synairgen plc
03 March 2022
Synairgen plc
('Synairgen' or the 'Company')
Update on SNG001 in the ACTIV-2 Phase 3 trial for COVID-19 and
on SNG001 activity against Delta and Omicron variants
Southampton, UK - 03 March 2022: Synairgen plc (LSE: SNG), the
respiratory company developing SNG001, a formulation for inhalation
containing the broad-spectrum antiviral protein interferon beta,
today announces an update on SNG001 in the ACTIV-2 Phase 3 trial
for COVID-19 and on SNG001 activity against Delta and Omicron
variants.
ACTIV-2 Phase 3 trial for COVID-19
Due to the need to modify the study design in light of the
emergence of the Omicron variant of SARS-CoV-2, the US National
Institutes of Health (NIH) ACTIV-2 trial team has asked Synairgen
to temporarily pause activities to prepare clinical supplies for
ACTIV-2 Phase 3 until the timeline for the activation of this agent
in the trial is clarified. Synairgen continues to await the Phase 2
data from the US NIH ACTIV-2 trial in home-based COVID-19
participants, expected by mid-year.
Update on SNG001 and Delta and Omicron variants
The Company also announced that in vitro studies conducted at
Viroclinics-DDL in the Netherlands have shown that SNG001 has
potent antiviral activity against SARS-CoV-2 Delta and Omicron
variants at concentrations that are readily achievable following
inhaled delivery of interferon beta.
Further SPRINTER Phase 3 analysis
As announced on 21 February 2022, Synairgen is in the process of
analysing the topline and full dataset from the SPRINTER Phase 3
study in order to better understand all of the findings. The
findings of this analysis will be announced without delay once
complete in accordance with regulatory obligations and presented
and/or published in a peer-review journal.
The SPRINTER trial pointed to an encouraging trend in prevention
of progression to severe disease and death (36% reduction in the
pre-defined per protocol population), which the Company and its
clinical advisors strongly believe merits further investigation in
a platf orm trial which the Company is actively investigating.
For further enquiries, please contact:
Synairgen plc
Brooke Clarke, Head of Communications
Brooke.Clarke@synairgen.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, 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
Notes for Editors
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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