Interim results for the six months ended 30 June 2021

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Synairgen plc
(‘Synairgen’ or the ‘Company’)

Interim results for the six months ended 30 June 2021

Scaling up and preparing for Phase III COVID-19 trial data read-out

Webcast today at 13:00 BST

Southampton, UK – 30 September 2021: Synairgen plc (LSE: SNG), the drug discovery, development and commercialisation company, today announces its unaudited interim results for the six months ended 30 June 2021.

Richard Marsden, CEO of Synairgen, said: “The need for an effective, broad-spectrum antiviral to treat patients hospitalised due to COVID-19 remains urgent. While vaccines have played an important role in reducing many of the risks associated with the SARS-CoV-2 virus, thousands of patients continue to require hospital treatment in the US and Europe every day with acute symptoms from COVID-19. This, coupled with the potential of waning immunity and the emergence of new SARS-CoV-2 variants, highlights the urgent need for additional effective antiviral therapies.

The Phase III SPRINTER trial of SNG001 is progressing well, with the last patient expected to be enrolled during November. SNG001 is an inhaled, broad-spectrum antiviral interferon beta (IFN-beta) formulation, which is delivered directly to the lower respiratory tract, stimulating the lungs’ immune defences, and has an established safety profile. Positive data from this trial would represent a major breakthrough in the battle against COVID-19. To ensure we can get this treatment to patients as quickly as possible, we are preparing to engage the US FDA on a potential application for Emergency Use Authorisation (EUA) and have aligned with partners with COVID-19 expertise for distribution and in-market support.

Operational highlights (including post period end)

Synairgen’s wholly-owned lead programme SNG001 has potential value in three settings:

  • COVID-19 patients hospitalised due to severe lower respiratory tract (LRT) symptoms;

  • Government stockpiling for future pandemic preparedness; and

  • Severe viral lung infections caused by regular common cold and flu viruses that lead to hospitalisation.

Earlier work establishing safety, dosing regimen, and patient selection, has been instrumental in paving the way for rapid and significant progress during this pandemic.

Phase III trial progress and preparation for regulatory submissions

  • Good progress with the global Phase III SPRINTER study of Synairgen’s interferon beta (IFN-beta) formulation, SNG001, being developed for hospitalised (non-ventilated) patients suffering from COVID-19 infection, with approaching 80% of trial participants enrolled to date. Due to the sporadic nature of the pandemic in different regions, we now expect the last patient to be enrolled during November, with top line results expected in early 2022

  • Progression of commercial scale manufacturing processes for drug substance and drug product