According to Synairgen, the external data safety monitoring board (DSMB) for the ACTIV-2 study of the company’s SNG001 nebulized interferon beta in mild to moderate COVID-19 patients has recommended that the company advance SNG001 into Phase 3. Synairgen said that it has not yet received any data from the ACTIV-2 trial. A Phase 3 trial of SNG001 in hospitalized COVID-19 patients was initiated in January 2021.
Synairgen CEO Richard Marsden commented, “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. In addition to the ACTIV-2 trial, our own Phase 3 SPRINTER study assessing SNG001 in hospitalized COVID19 patients, is also progressing well and we expect top-line results in early 2022.”
Chief Scientific Officer Phillip Monk noted, “Interferon beta is a naturally-occurring protein, which orchestrates the body’s antiviral responses. SARSCoV-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 defenses to prevent the virus from causing severe lower respiratory tract illness. Unfortunately, despite vaccination programs and early interventions, thousands of patients are still hospitalized every day due to COVID-19-induced breathing difficulties. Data to date suggests SNG001 is well tolerated with a favorable 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.”
“ACTIV” refers to the Accelerating COVID-19 Therapeutic Interventions and Vaccines initiative, which is sponsored by the National Institutes of Health.
Read the Synairgen press release.
