Brii Biosciences Limited, a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, 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.
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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.