By IDSE News Staff
Interim results from a phase 3 trial showed that the experimental BRII-196/BRII-198 neutralizing monoclonal antibody being developed by Brii Biosciences 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 of COVID-19, according to a presentation at IDWeek 2021 (abstract LB2).
These initial results suggest that combination BRII-196/BRII-198 may remain effective in many patients who are late to treatment, potentially extending its clinical benefit in a real-world setting, where rapid access to care can be a challenge.
Overall, BRII-196/BRII-198 reduced the risk for hospitalization and death over placebo by 78% in 837 outpatients at high risk for clinical progression. Through the 28-day primary end point, zero (n=418) deaths were observed on BRII-196/BRII-198 versus eight (n=419) deaths on the placebo arm.
Of those patients 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 patients 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 AEs or infusion reactions observed.
“We’re very encouraged by the significant reduction of hospitalizations or death among COVID-19 outpatients at high risk of clinical progression, with these interim phase 3 results demonstrating that BRII-196/BRII-198 may have clinical utility in patients presenting as late as 10 days after symptom onset, providing another solution to health care providers and institutions that continue to deal with increasing hospital admission rates and an overburdened system,” said Teresa H. Evering, MD, MS, a co-lead investigator of BRII-196/BRII-198 in the ACTIV-2 trial and study presenter of the phase 3 data at IDWeek. “We look forward to continuing to evaluate the full data set from this global trial, including the potential effects of BRII-196/BRII-198 on circulating COVID-19 variants that are driving new cases of COVID-19 around the world,” said Dr. Evering, of Weill Cornell Medicine in New York City.
“As we continue to grapple with the global effects of this pandemic, including increased incidence of disease based on current and newly emerging variants, it is imperative that we prioritize and progress the development of safe and effective therapies for the prevention of severe disease,” said Eric S. Daar, MD, of the Lundquist Institute at Harbor-UCLA Medical Center, in Torrance, Calif., and a co-lead investigator of BRII-196/BRII-198 in ACTIV-2.
Based on these findings and the growing body of evidence supporting the use of combination BRII-196/BRII-198, Brii plans to submit an application for emergency use authorization to the FDA by the end of the year and will continue to pursue additional regulatory filings in both established and emerging global markets.
Phase 3 of the ACTIV-2 trial was conducted at clinical sites around the world, including the United States, Brazil, South Africa, Mexico, Argentina and the Philippines, enrolling patients between January and July 2021—a period of rapid global emergence of novel SARS-CoV-2 variants. Study participants had the following baseline demographics: median age of 49 years, 51% women, 49% Hispanic/Latino ethnicity and 17% Black/African American. Data on the clinical efficacy of combination BRII-196/BRII-198 by variant type are also being evaluated as part of the study.
