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Phase III ACTIV-2 trial interim data for BRII 196 + BRII 198 shows benefits for high-risk outpatients

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Published:27th Aug 2021
Brii Biosciences announced that its SARS-CoV-2 (virus that causes COVID-19) neutralizing monoclonal antibody combination therapy, BRII 196/BRII 198 demonstrated a statistically significant reduction of 78%, relative risk ([95% CI]: 0.22 [0.05, 0.86], p<0.00001 (nominal, one-sided)) in the combined endpoint of hospitalization and death compared with placebo in 837 non-hospitalized covid-19 patients at high risk of clinical progression.>

In this interim analysis of the activ-2 trial based on partial follow-up of the 837 participants, a reduction in both hospitalizations (12 active vs. 45 placebo) and deaths (1 active vs. 9 placebo) was observed.></0.00001>

Additional subgroup analysis may further delineate the clinical benefits of early (up to 5 days) versus late (6-10 days) treatment with BRII-196/BRII-198 following symptom onset, providing unique insight to inform real-world treatment decisions. The BRII-196/BRII-198 arm of the Phase II/III ACTIV-2 platform trial, which is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), evaluated 837 outpatients, enrolled within 10 days of symptom onset and at high risk of clinical progression (i.e. age at least 60 or the presence of other medical conditions at any age).

Following a clear demonstration of statistical significance, which evaluated approximately 69% of participants through the primary endpoint as part of a pre-specified review, the independent data safety monitoring board (DSMB) permitted the early release of these results while the complete study follow-up remains ongoing. The participants enrolled are evaluated for the combined primary endpoint of hospitalizations and death relative to placebo in the 28 days following treatment. Grade 3 or higher adverse events (AEs) were observed less frequently among the BRII-196/BRII-198 arm (3.8% active vs. 13.4% placebo), with few events being considered drug related. There were no drug related serious adverse events (SAEs) or deaths observed in either arm. There were no severe infusion reactions observed.

Condition: Coronavirus/COVID-19 Infection
Type: drug

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