Brii Biosciences advances COVID-19 candidate BRII-196/BRII-198

China’s Brii Biosciences (HK: 2137) has announced that the Phase III portion of the ACTIV-2 study evaluating its monoclonal neutralizing antibody combination therapy, BRII-196/BRII-198 has completed enrollment of 846 participants, in sites in the USA, Brazil, South Africa, Mexico and Argentina.

The Phase III portion of the ACTIV-2 trial, which is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the USA’s National Institutes of Health (NIH), evaluates outpatients at high risk of clinical progression who presented with symptomatic COVID-19 both early (≤5 days) and late (5-10 days) following symptom onset. The participants enrolled are being evaluated for the combined primary endpoint of hospitalizations and death, relative to placebo, in the 28 days following treatment. Upon completion of the study, the analysis of the ACTIV-2 dataset will include participants enrolled between January and July of 2021 – a period of rapid global emergence of novel SARS-CoV-2 variants.

Combination BRII-196/BRII-198 was generally safe and well tolerated in Phase I and Phase II clinical trials conducted to date. The Phase II clinical trial in China ( NCT04787211) is ongoing. In response to the recent emergence of COVID-19 cases in China, including cases caused by the Delta variant, Brii Bio has cooperated with governmental agencies and hospitals in China to supply BRII-196/BRII-198 for emergency use in Guangzhou, Shenzhen, Ruili, Kunming, Nanjing and Yangzhou.