Brii Biosciences has been given the green light to proceed with a phase 3 trial for a COVID-19 combination therapy in ambulatory care patients after the National Institutes of Health shut down a study of hospitalized patients in March.
The monoclonal antibody combination therapy, BRII-196 and BRII-198, is part of a clinical trial called ACTIV-2 that is being conducted by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases. The NIH previously stopped a clinical assessment of the combo in hospitalized patients for futility, but development was allowed to proceed for ambulatory care patients.
An independent data safety monitoring board has now determined that Brii’s therapy, which is created using plasma recovered from COVID-19 patients, has met safety and efficacy thresholds allowing for the continuation of the late-stage study in ambulatory care patients at high risk for progression to severe disease.
RELATED: NIH stops trial of Brii's COVID-19 antibodies in hospitalized patients for futility
The phase 3 study will now be expanded around the world, which Brii said could allow for data to be collected on effectiveness against some of the prominent SARS-CoV2 variants causing waves of infections around the world.
Brii is just one of many biotechs and Big Pharmas desperately trying to improve on the COVID-19 care standard set by Gilead’s Veklury, still the only antiviral therapy FDA-approved for hospitalized patients with COVID-19. A trial for Eli Lilly’s bamlanivimab was shut down by the NIH last year for futility, as was a sub-study testing a Vir Biotechnology-GlaxoSmithKline therapeutic in March.
Several monoclonal antibody treatments have been authorized for use in patients with less severe illness from COVID-19, including those made by Eli Lilly and Regeneron.