Monoclonal Neutralizing Antibody Combo for the Treatment of COVID-19 Completes Phase 3 Enrollment
China-based Brii Biosciences Limited announced that the Phase 3 portion of the ACTIV-2 study evaluating its monoclonal neutralizing antibody combination therapy, BRII-196/BRII-198, has completed enrollment of 846 participants in sites in the USA, Brazil, South Africa, Mexico, and Argentina.
The participants enrolled are being evaluated for the combined primary endpoint of hospitalizations and death, relative to placebo, in the 28 days following treatment.
Upon completion of the study, the analysis of the ACTIV-2 dataset will include participants enrolled between January and July of 2021 – a period of the rapid global emergence of novel SARS-CoV-2 variants.
In addition, data on the clinical efficacy of combination BRII-196/BRII-198 by variant type will also be evaluated as part of the study analysis.
BRII-196/BRII-198 have been specifically engineered to reduce the risk of antibody-dependent enhancement and prolong the plasma half-lives for a potentially more durable treatment effect. In addition, their non-overlapping epitope binding regions provide a high degree of neutralization activity against SARS-CoV-2.
Current in vitro pseudovirus testing data suggests that combination BRII-196/BRII-198 retains activity against major SARS-CoV-2 coronavirus variants of concern, including the following commonly identified variants, B.1.1.7 (Alpha), (B.1.351 (Beta), P.1 (Gamma), B.1.429 (Epsilon) and B.1.617.2 (Delta).
Combination BRII-196/BRII-198 was generally safe and well-tolerated in Phase 1 and Phase 2 clinical trials.
The ACTIV-2 trial is sponsored by NIAID, one of the institutes of the U.S. NIH, and is led by the NIAID-funded AIDS Clinical Trials Group (ACTG). ACTIV-2 is part of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership program to create a coordinated research strategy that prioritizes and speeds the development of the most promising treatments and vaccines.
BRII-196 and BRII-198 are non-competing SARS-CoV-2 monoclonal neutralizing antibodies derived from convalesced COVID-19 patients.
Investigational New Drug applications have been submitted for the combination therapy to the U.S. Food and Drug Administration, the China National Medical Products Administration, and the Department of Health in Hong Kong, China.
Brii Biosciences Limited is a biotechnology company based in Beijing, China, and the United States, committed to advancing therapies for significant infectious diseases, such as hepatitis B virus, human immunodeficiency virus, multi-drug resistant, or extensive drug-resistant gram-negative infections, and other illnesses, such as the central nervous system diseases.
For more information, visit www.briibio.com.