REG - Synairgen plc - Update on SNG001

SynairgenAnnouncement

03/03/2022 07:00

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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 platform trial which the Company is
actively investigating.

For further enquiries, please contact:

Synairgen plc

Brooke Clarke, Head of Communications

Brooke.Clarke@synairgen.com (mailto: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 (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 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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