FDAnews
www.fdanews.com/articles/201736-nih-ends-enrollment-in-brii-biosciences-covid-19-antibody-trial

NIH Ends Enrollment in Brii Biosciences’ COVID-19 Antibody Trial

March 8, 2021

Brii Biosciences announced that its investigational monoclonal antibodies BRII-196 and BRII-198 failed to reach the minimum required efficacy rate for hospitalized patients and will not move on to the late stage of the National Institutes of Health’s (NIH) ACTIV-3 trial.

The NIH evaluated the safety and efficacy of the antibodies as a combination treatment in approximately 150 hospitalized patients, but the trial’s data and safety monitoring board determined the pre-specified efficacy criteria for the hospitalized population was not met, so the study will not be expanded to enroll more participants.

“While we are disappointed that BRII-196 and BRII-198 have not shown clear benefits during the interim analysis against COVID-19 in hospitalized patients receiving the current standard of care, we remain committed to investigating this antibody combination in ambulatory COVID-19 patients through the ongoing ACTIV-2 trial,” said Brii Biosciences CEO Zhi Hong.