Synairgen Regulatory News (SNG)

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 

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.