Synairgen has developed and is testing an inhaled formulation of interferon beta, a naturally occurring protein which orchestrates the body's antiviral responses. Viruses, including coronaviruses, have evolved mechanisms which suppress natural IFN-β production, thereby helping the virus evade the immune system.[11]
Richard Marsden, the company's chief executive, said one of the main ways viruses evaded the immune system was “to suppress the production of interferon beta”, which plays a significant role in activating the wider immune response and preventing a virus from replicating. “All we’re doing is putting . . . this protein, that everyone makes, back into the battleground, and the battleground that matters is in the lungs,” Marsden said.[12]
In March 2020,[13] Synairgen initiated a placebo-controlled Phase 2 trial of SNG001, an inhaled form of interferon beta, in COVID-19 patients in the UK.
In July 2020, Synairgen announced SNG001 lowered the risk of severe COVID-19 in infected patients in a small clinical trial. The details of the study were published in Lancet in November 2020.[14]
The Phase 3 SPRINTER trial (SG018), a randomised, double-blind, placebo-controlled study evaluating SNG001 for the treatment of hospitalised COVID-19 patients, was initiated in January 2021.[15] It completed enrolment of 610 patients in November 2021[16] across 17 countries.
SNG001 is also being investigated independently as part of the US National Institute of Health's ACTIV-2 (Accelerating COVID-19 Therapeutic Interventions and Vaccines) programme [17] to accelerate the development of the most promising COVID-19 treatments.
The ACTIV-2 study, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and led by the NIAID-funded AIDS Clinical Trials Group (ACTG), is testing agents in outpatient adults with documented positive SARS-CoV-2 infection and symptoms of COVID-19. Synairgen's SNG001 was advanced into Phase 3 in October 2021.[18]
^Holgate, Stephen; Agusti, Alvar; Strieter, Robert M.; Anderson, Gary P.; Fogel, Robert; Bel, Elisabeth; Martin, Thomas R.; Reiss, Theodore F. (2015). "Drug development for airway diseases: looking forward". Nature Reviews Drug Discovery. 14 (6): 367–368. doi:10.1038/nrd4645. ISSN1474-1776. PMID26000726. S2CID8539798.