Investigational inhaled COVID-19 treatment graduates to phase 3 in ACTIV-2 trial

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. 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."

Judith Currier, M.D., M.Sc., ACTG Chair, University of California, Los Angeles (UCLA)

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.

ACTIV-2 is a randomized, blinded, controlled adaptive platform that allows promising therapies to be added and removed over the course of the study to efficiently test a variety of new agents within the same trial infrastructure. The SNG001 study is being led by William Fischer, M.D., University of North Carolina (UNC) and Upinder Singh, M.D., and Prasanna Jagannathan, M.D., both of Stanford University. ACTIV-2 is led by Kara W. Chew, M.D., M.S., UCLA and Davey Smith, M.D., University of California, San Diego (protocol chairs) and David Alain Wohl, M.D., UNC and Eric S. Daar, M.D., Lundquist Institute at Harbor-UCLA Medical Center (vice-chairs) and supported by Dr. Currier and ACTG Co-Chair Joseph J. Eron, M.D., UNC.

ACTIV-2 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Insititutes of Health (NIH), which also funds the ACTG. ACTIV-2 is part of NIH's Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership program to create a coordinated research strategy that prioritizes and speeds development of the most promising treatments and vaccines. It also receives support from the Federal COVID Response-Therapeutics, the U.S. government's multi-agency effort to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.