Inhaled COVID-19 Treatment Advances to Phase 3 Study

The AIDS Clinical Trials Group (ACTG), the largest global HIV research network, which recently expanded its focus to include evaluating outpatient treatment for COVID-19, today announced that the external data and safety monitoring board (DSMB) has recommended that SNG001, an inhaled formulation of interferon beta, advance to phase 3 in the ACTIV-2 Outpatient Monoclonal Antibodies and Other Therapies Trial (ACTG A5401). SNG001 is the third agent to graduate to phase 3 in ACTIV-2, which is evaluating multiple investigational agents to treat early, symptomatic COVID-19 in non-hospitalized individuals. For more information about the trial, please visit the study website.

ACTIV-2 is the first U.S. study to evaluate SNG001 (developed by Synairgen) among non-hospitalized people with COVID-19. SNG001 is self-administered as a nebulized dose (15.6 MIU) that participants inhale once daily for 14 days. Participants are trained to use the nebulizer device by study staff and take all doses at home. BRII-196/BRII-198 (a combination monoclonal antibody treatment) and SAB-185 (a novel polyclonal antibody therapy) are both currently also in phase 3 study in ACTIV-2.

“ACTIV-2 is currently evaluating treatment options that can be delivered in different ways, which is important as we aim to identify solutions that work for people who have a variety of needs,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California, Los Angeles (UCLA). “In addition to a combination monoclonal antibody infusion and polyclonal antibody infusion, this nebulized, inhaled version of interferon beta broadens potential treatment options for people who have COVID-19 but are not hospitalized, which we believe could significantly simplify care for some people with COVID-19.”

The ACTIV-2 DSMB recommended that SNG001 advance into a phase 3 study among participants with mild to moderate COVID-19. The planned phase 3 study will evaluate the safety and efficacy of SNG001 in reducing the risk of hospitalization and death among non-hospitalized adults with COVID-19.

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