Synairgen PLC (AIM:SNG, OTC:SYGGF) said its anti-viral treatment for severe lung infections will advance to the final stage of trials as part of a US government-sponsored programme.
The external data safety monitoring board of the ACTIV-2 study recommended Synairgen’s SNG001 go to Phase III trials in mild to moderate COVID-19 patients.
SNG001 is a formulation for inhalation containing the broad-spectrum anti-viral protein interferon beta, a naturally occurring protein that orchestrates the body's antiviral responses.
ACTIV-2 is testing treatments in non-hospitalised adults experiencing mild to moderate COVID-19 and is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health.
Phillip Monk, chief scientific officer of Synairgen, explained: “SARS-CoV-2 suppresses IFN-beta production to compromise the immune system; the aim of delivering SNG001 directly into the lungs is to restore or boost natural antiviral defences to prevent the virus from causing severe lower respiratory tract illness.
“Unfortunately, despite vaccination programmes and early interventions, thousands of patients are still hospitalised every day due to COVID-19-induced breathing difficulties. Data to date suggests SNG001 is well tolerated with a favourable safety profile and there is growing evidence to support the rationale for delivering IFN-beta directly into the lungs to counter the effects of SARS-CoV-2."
Synairgen chief executive officer Richard Marsden added: "The advancement of SNG001 from Phase 2 to Phase 3 of the large ACTIV-2 trial is very welcome news and continues to build the case that our formulation of inhaled IFN-beta may have an important role in combatting COVID-19 and future emerging virus threats.”
As well as the ACTIV-2 trial, the company is also carrying out its own Phase III trial, called SPRINTER, which is assessing SNG001 in hospitalised COVID-19 patients and expects to publish top-line results in early 2022.