April 29, 2021 -- Brii Biosciences announced that it is enrolling patients in a phase III trial of its monoclonal antibody (mAb) combination therapy, BRII-196 and BRII-198, after meeting phase II safety and efficacy criteria.
The combination therapy will be evaluated as part of the U.S. National Institutes of Health's Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-2 trial in ambulatory COVID-19 patients. In the phase II study, safety and efficacy was established in a group of 220 ambulatory patients with COVID-19 who were at high risk for progression to severe disease.
The phase III study includes international trial sites, which will allow a broader assessment of the BRII-196 and BRII-198 combination in ambulatory COVID-19 patients. In addition, the company stated the trial may include data on how its candidate therapy performs against newly emerged SARS-CoV-2 variants.
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