Brii Biosciences Announces Positive Data Demonstrating its Long-Acting COVID-19 Neutralizing Antibody Therapy, Amubarvimab/Romlusevimab Combination, Retains Neutralizing Activity Against Live Omicron Virus BA.4/5 and BA.2.12.1 Subvariants
07/26/2022 - 07:00 PM
Independent lab results demonstrate that the combination therapy retains neutralizing activity against currently dominant COVID-19 strains, as previously demonstrated with all variants of concern to date
The amubarvimab/romlusevimab combination is commercially available in China and is under review for Emergency Use Authorization by the U.S. Food and Drug Administration (FDA)
DURHAM, N.C. and BEIJING , July 26, 2022 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK), a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, today announced new live virus data confirming that the amubarvimab/romlusevimab combination, a long-acting COVID-19 monoclonal antibody (mAb) therapy, retains neutralizing activity against the Omicron BA.4/5 and BA.2.12.1 SARS-CoV-2 subvariants.
Data from the live virus neutralization assay performed at a University of Maryland lab certified by the U.S. National Institutes of Health (NIH) and National Institute of Allergy and Infectious Diseases (NIAID) predict that total serum concentrations of the amubarvimab/romlusevimab combination will remain greater than 170 times the level required for greater than 90% neutralization (Neut99: 0.94 μg/mL) against the live virus, 14 days post dose. As a result, adequate therapeutic exposures are expected to persist throughout the treatment period.
The mutations found in the BA.4/5 and BA.2.12.1 subvariants spike protein confer a limited reduction in neutralization activity from wild-type SARS-CoV-2. Based on the human pharmacokinetic data gathered on the amubarvimab/romlusevimab combination, exposures of intravenous amubarvimab 1000mg and romlusevimab 1000mg are expected to remain above the level required for neutralizing activity against BA.4/5 and BA.2.12.1, for the treatment of COVID-19.
"As the COVID-19 pandemic continues to surge with evolving variants, these data further validate the durability and longevity of our long-acting amubarvimab/romlusevimab combination treatment and reinforce its position as a leading investigational monoclonal antibody therapy with potential to retain activity against the most dominating strains that are circulating worldwide," said David Margolis , M.D., MPH, Vice President and Head of Infectious Diseases Therapy Area at Brii Bio. "We're at a critical moment in the pandemic in which the new Omicron subvariants are more contagious, resulting in a sustained urgency for safe and effective treatment options. We look forward to continuing our discussions with global regulatory bodies as we work to advance this innovative combination therapy for COVID-19 patients in need around the world."
On December 8, 2021 , the National Medical Products Administration (NMPA) of China approved the amubarvimab/romlusevimab combination for the treatment of adults and pediatric patients (age 12-17 weighing at least 40 kg) with mild and normal type of COVID-19 at high risk for progression to severe disease, including hospitalization or death. The indication of pediatric patients (age 12-17 weighing at least 40 kg) is under a conditional approval. On March 15, 2022 , the National Health Commission of China added the amubarvimab/romlusevimab combination to its COVID-19 Diagnosis and Treatment Guidelines (9th Pilot Edition) for the treatment of COVID-19. On July 7, 2022 , the amubarvimab/romlusevimab combination was made commercially available in China .
The U.S. FDA is currently reviewing Brii Bio's Emergency Use Authorization application for the amubarvimab/romlusevimab combination.
About Long-Acting COVID-19 Neutralizing Antibody Therapy, Amubarvimab/Romlusevimab Combination
Amubarvimab and Romlusevimab are non-competing SARS-CoV-2 monoclonal neutralizing antibodies derived from convalesced COVID-19 patients developed in collaboration with the 3rd People's Hospital of Shenzhen and Tsinghua University. They have been specifically engineered to reduce the risk of antibody-dependent enhancement and prolong the plasma half-lives for potentially more durable treatment effect.
Based on the final results from the U.S. National Institutes of Health (NIH)/National Institute of Allergy and Infectious Diseases (NIAID)-sponsored ACTIV-2 Phase 3 clinical trial with 837 enrolled outpatients, the amubarvimab/romlusevimab combination demonstrates a statistically significant 80% reduction of hospitalization and death with fewer deaths through 28 days in the treatment arm (0) relative to placebo (9), and improved safety outcome over placebo in non-hospitalized COVID-19 patients at high risk of clinical progression to severe disease. Similar efficacy rates were observed in participants initiating therapy early (0-5 days) and late (6-10 days), following symptom onset, providing critically needed clinical evidence in COVID-19 patients who were late for treatment.
The live virus testing data, as well as pseudovirus testing data from multiple independent labs, have demonstrated that the amubarvimab/romlusevimab combination retains activity against major SARS-CoV-2 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), B.1.617.2 (Delta), AY.4.2 (Delta Plus), C.37 (Lambda), B.1.621 (Mu), B.1.1.529-BA.1 (Omicron), and BA.1.1, BA.2, BA.2.12.1, BA.4/5 (Omicron subvariants).
About Brii Bio
Brii Biosciences Limited ("Brii Bio", or the "Company", stock code: 2137.HK) is a biotechnology company based in China and the United States committed to advancing therapies for significant infectious diseases, such as hepatitis B, COVID-19, human immunodeficiency virus (HIV) infection, multi-drug resistant (MDR) or extensive drug resistant (XDR) gram-negative infections, and other illnesses, such as the central nervous system (CNS) diseases, which have significant public health burdens in China and worldwide. For more information, visit www.briibio.com .
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