Infectious Disease

Monoclonal Antibody Combination Reduces COVID-19 Hospital Admissions And Deaths By Nearly 80%

August 28, 2021

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Preliminary Phase 3 data released by Brii Biosciences showed that the company’s monoclonal antibody combination therapy reduced the composite endpoint of COVID-19 hospital admissions and deaths in high-risk patients by 78% compared to placebo.

According to a press release issued by the company, the combined treatment arm BRII-196 / BRII-198 of the ongoing Phase 2/3 ACTIV-2 platform study evaluated 837 patients enrolled within 10 days of COVID-19 symptoms and at high risk for the clinical course.

Source: Adobe Stock.

Source: Adobe Stock.

The researchers rated participants for the composite primary endpoint of hospitalizations and death versus placebo in the 28 days after treatment. The study is sponsored by the National Institute of Allergy and Infectious Diseases.

According to Brii, the preliminary data showed that combination therapy reduced the combined endpoint of hospitalization (12 in the treatment group vs. 45 in the placebo group) and death (one in the treatment group vs. nine in the placebo group) by 78%. Additionally, Grade 3 or higher adverse events were observed less frequently in the combination treatment arm (3.8% active vs. 13.4% placebo), with few events considered drug-related, the press release said.

“We are pleased to announce the preliminary Phase 3 results of ACTIV-2, which will significantly reduce the endpoint of hospital admissions or deaths in non-hospitalized people with mild COVID-19 who are infected with BRII-196 / BRII- 198 have been treated. ” Teresa H. Evering, MD, MS, Co-lead investigator of the study and assistant professor of medicine at Weill Cornell Medicine, said in the press release. “The devastating resurgence of COVID-19 cases over the past few months is a sobering reminder of the desperate need for treatment options.”

After completion of the ACTIV-2 study, the full analysis data set between January and July 2021 in the USA and participants enrolled in Brazil, South Africa, Mexico, Argentina and the Philippines will also include the combination therapy according to variant type will be evaluated.

The FDA has approved several monoclonal antibodies to treat COVID-19, including the combination of bamlanivimab and etesevimab, which is approved for use in patients 12 years and older, and sotrovimab, which has received emergency approval for mild to moderate COVID-19 patients in whom there is a risk of progression to serious illness, and Regeneron’s antibody cocktail as post-exposure prophylaxis.

In addition, the Infectious Diseases Society of America has proposed the use of some neutralizing antibodies to treat patients who are at high risk of progression to a serious disease.

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