Monoclonal antibody combination reduces COVID-19 hospitalizations, deaths by nearly 80%
Interim phase 3 data released by Brii Biosciences showed that the company’s monoclonal antibody combination therapy reduced the combined endpoint of COVID-19 hospitalizations and death by 78% in high-risk patients compared with placebo.
According to a press release issued by the company, the combination BRII-196/BRII-198 treatment arm of the ongoing phase 2/3 ACTIV-2 platform trial evaluated 837 patients enrolled within 10 days of COVID-19 symptom onset and at high risk for clinical progression.
Researchers evaluated the participants for the combined primary endpoint of hospitalizations and death relative to placebo in the 28 days following treatment. The trial is sponsored by the National Institute of Allergy and Infectious Diseases.
According to Brii, interim data showed that the combination therapy demonstrated a 78% reduction in the combined endpoint of hospitalization (12 in the therapy group vs. 45 in the placebo group) and death (one in the therapy group vs. nine in the placebo group). Additionally, grade three or higher adverse events were observed less frequently among the combination treatment arm (3.8% active vs. 13.4% placebo), with few events being considered drug related, according to the press release.
“We are thrilled to announce the interim phase 3 results from ACTIV-2, which demonstrate a significant reduction in the endpoint of hospitalizations or death among nonhospitalized people with mild COVID-19 who were treated with BRII-196/BRII-198," Teresa H. Evering, MD, MS, co-lead investigator on the trial and an assistant professor of medicine at Weill Cornell Medicine, said in the release. "The devastating resurgence in COVID-19 cases over the past several months is a sobering reminder of how desperately we need treatment options."
Once the ACTIV-2 study is completed, the full analysis dataset will include participants enrolled in the U.S., as well as Brazil, South Africa, Mexico, Argentina and the Philippines between January and July 2021. According to Brii, data on the efficacy of the combination therapy by variant type also will be evaluated.
The FDA has authorized several monoclonal antibodies to treat COVID-19 including the combination of bamlanivimab and etesevimab, which is authorized for patients aged 12 years or older, and sotrovimab, which received an emergency use authorization for mild-to-moderate COVID-19 in patients at risk for progressing to severe disease and Regeneron’s antibody cocktail as a postexposure prophylaxis.
Additionally, the Infectious Diseases Society of America has suggested the use of some neutralizing antibodies to treat patients who are at high risk for progression to severe disease.