Monoclonal antibodies could play a vital role in the battle against COVID-19. To date, such infusion-delivered antibodies from Eli Lilly (NYSE:LLY) and Regeneron Pharmaceuticals (NSDQ:REGN) have received emergency use authorization from FDA.
Now, a phase 2/3 clinical trial will study the potential of investigational monoclonal antibody therapy for patients with mild-to-moderate COVID-19.
The antibodies, known as BRII-196 and BRII-198, are licensed to Brii Biosciences, a Beijing-based company. Phase 1 trials for COVID-19 infections commenced in July 2020.
The National Institute of Allergy and Infectious Diseases (NIAID) will sponsor the phase 2/3 trial as part of the ACTIV-2 master protocol, which is assessing the potential of several experimental therapies to treat mild-to-moderate COVID-19. The ACTIV-2 trial began in August 2020 with an investigation of another monoclonal antibody, LY-CoV555, from Lilly and AbCellera Biologics (NSDQ:ABCL).
The NIAID-backed AIDS Clinical Trials Group will lead the trial, which will initially enroll 220 participants internationally. Half of those volunteers will receive placebo infusions.
An independent Data and Safety Monitoring Board (DSMB) can authorize the transition to a Phase 3 trial if the antibodies meet safety and efficacy endpoints.