Our team started asking questions about the role inhaled IFN-β might play in helping the respiratory system behave in the way it is designed to. By delivering IFN-β directly to the lungs through inhalation, could it be successful in switching on the body’s natural defences to clear the virus? By March 2020, we had initiated a placebo-controlled Phase 2 trial in COVID-19 patients in the UK. And by January 2021, our Phase 3 trial which would ultimately include 17 countries, had begun.
SNG001 was also being investigated independently as part of
the US National Institute of Health’s ACTIV programme to accelerate the
development of the most promising COVID-19 treatments. The ACTIV-2 study (ClinicalTrials.gov Identifier:
NCT04518410), sponsored by the National Institute of Allergy and
Infectious Diseases (NIAID). In October 2021, the Data Safety Monitoring Board recommended graduation of SNG001, based on data from the Phase 2 trial, to Phase 3. However, as the Company and the ACTIV-2 team were preparing to initiate recruitment for Phase 3, the NIAID halted all patient recruitment in ACTIV-2 and discontinued all arms of the trial, including the one to evaluate SNG001.
Read more about SG018 at clinicaltrials.gov
Synairgen reported topline results of SPRINTER (SG018) in February 2022, and a more detailed full analysis including post hoc analyses at the ATS International Conference in May 2022.
In September 2022, Synairgen announced positive findings from the analysis of data from 60 and 90-day follow-up visits (Long COVID) from SG018.
This is a pilot trial requested by regulators to validate the additional questions that are included in SG018 which determine the OSCI score when patients have been discharged from hospital. The study is proceeding on time and as it is an independent study, will not delay the SPRINTER study (SG018).
Read more about SG019 at clinicaltrials.gov