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 in vitro pseudoviris neutralization data demonstrating that its amubarvimab/romlusevimab combination therapy (previously referred to as combination BRII-196/BRII-198) retains activity against the new Omicron SARS-CoV-2 variant (B.1.1.529).
These data add to the growing body of evidence demonstrating that the amubarvimab/romlusevimab combination retains activity against key World Health Organization's COVID-19 variants of concern, also including Delta (B.1.617.2) and Delta Plus (AY.4.2).
"We believe the amubarvimab/romlusevimab combination has the potential to be a best-in-class treatment option for a broad range of high risk COVID-19 patients. These latest findings underscore that our combination antibody therapy holds up well against the Omicron variant that pose a significant public health threat worldwide," said Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio. "As experts around the world continue to track Omicron and other variants of concern, independent labs have demonstrated that our combination therapy will continue to provide clinical benefits for both patients who present early for treatment and those who present late for treatment. We look forward to continuing our work with the U.S. FDA and regulatory authorities around the world to bring our combination therapy to patients in need as quickly as possible."
The in vitro tests against pseudovirus from independent labs have demonstrated the Omicron variant remains susceptible to neutralization by the amubarvimab/romlusevimab combination. While there was substantial drop in activity for amubarvimab against the Omicron variant, romlusevimab was not impacted by the omicron variant. Together, the combination therapy retains neutralizing activity against the Omicron variant, validating the importance of a combination mAb strategy to ensure clinical benefits forpatients at high risk for clinical progression. Specific data will be presented in scientific publications in the near future.
"These new preclinical data provide further evidence of that the amubarvimab/romlusevimab combination provides significant benefits for high risk patients who contract the Omicron variant, given its highly successful track record thus far to reduce hospitalization and death among all tested variants of concern, including the Delta variant, " said David Margolis, M.D., MPH, Vice President and Head of Infectious Diseases Therapy at Brii Bio. "As a combination therapy, amubarvimab/romlusevimab offer the unique ability to protect each other against the emerging variants and potentially provide a more durable treatment option against COVID variants in the long term as we continue fighting to save lives and reduce the severe health consequences of this pandemic."
The FDA is currently reviewing Brii Bio's EUA application for the amubarvimab/romlusevimab combination. The application is based on data that show the amubarvimab/romlusevimab combination demonstrated a statistically significant 80% reduction of hospitalization and death and improved safety over placebo in non-hospitalized COVID-19 patients at high risk of clinical progression to severe disease. The proportion of deaths from any cause was observed to be significantly less (p=0.0037) on the amubarvimab/romlusevimab combination treatment (n=0) compared to placebo (n=9) from study Day 0 through Day 28. Similar efficacy rates were observed in participants initiating therapy early (0-5 days) and late (6-10 days), following symptom onset, providing critically needed therapeutic option to patients with challenges in timely access to care who may present later.
Conference Call
Brii Bio management will host a conference call on Monday, 13 December, 2021 at 8:30 a.m. Hong Kong, S.A.R., China time to discuss the details. To access the live conference call, p...
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