SARS-CoV-2 Monoclonal Neutralizing Antibody Therapy Has Utility After Symptom Onset
North Carolina-based Brii Biosciences Limited presented interim results from Phase 3 of the ACTIV-2 trial, which showed that BRII-196/BRII-198 (“combination BRII-196/BRII-198”), the Company’s neutralizing monoclonal antibody (mAb) combination therapy for SARS-CoV-2 virus infection, achieved a similar reduction in hospitalization or death among patients who initiated treatment early (within five days) versus late (six to 10 days) following symptom onset.
Overall, BRII-196/BRII-198 reduced the risk of hospitalization and death over placebo by 78% in 837 outpatients at high risk of clinical progression.
These initial results suggest that combination BRII-196/BRII-198 may remain effective in most patients who are late to treatment, potentially extending its clinical benefit in a real-world setting.
Of those subjects who received treatment with BRII-196/BRII-198 within five days of symptom onset, 2% (4/196) progressed to hospitalization or death, compared with 11% (21/197) in the placebo arm.
Similarly, 2% (5/222) of subjects who received treatment with BRII-196/BRII-198 at six to 10 days following symptom onset progressed to hospitalization or death, compared with 11% (24/222) of those receiving placebo.
Grade 3 or higher adverse events (AEs) were less common in the BRII-196/BRII-198 treatment arm versus placebo, 3.8% (16/418) versus 13.4% (56/419), with no drug-related severe adverse events (SAEs) or infusion reactions observed.
Based on these findings and the growing body of evidence supporting the use of combination BRII-196/BRII-198, Brii Bio plans to apply for Emergency Use Authorization to the U.S. Food and Drug Administration by the end of 2021.
In addition, it will continue to pursue additional regulatory filings in both established and emerging global markets.
“We’re very encouraged by the significant reduction of hospitalizations or death among COVID-19 outpatients at high risk of clinical progression. With this interim Phase 3 results demonstrating that BRII-196/BRII-198 may have clinical utility in patients presenting as late as ten days after symptom onset, providing another solution to healthcare providers and institutions that continue to deal with increasing hospital admission rates and an overburdened system,” said Teresa H. Evering, M.D., M.S., Weill Cornell Medicine, co-lead investigator of BRII-196/BRII-198 in ACTIV-2.
These findings were presented in an oral late-breaker presentation at the IDWeek 2021 annual meeting on September 30, 2021. The Company previously announced interim top-line results from Phase 3 of the ACTIV-2 trial on August 25, 2021.
Brii Biosciences Limited is a biotechnology company based in China, and the United States committed to advancing therapies for significant infectious diseases.
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