Brii Biosciences (HK: 2137) of Beijing committed an additional $100 million for global regulatory filings and commercialization of its SARS-CoV-2 combination therapy. BRII-196/BRII-198 is a neutralizing monoclonal antibody combination therapy. In a Phase III trial, interim results showed a statistically significant reduction of 78% in hospitalization/death among high risk, non-hospitalized COVID-19 patients. The results showed efficacy in all variants of the disease, with fewer grade three or above adverse effects than placebo. The company will also expand manufacturing and establish partnerships to deliver the therapy globally.

The study was conducted at clinical trial sites around the world, including the US, Brazil, South Africa, Mexico, Argentina and the Philippines. Patients were enrolled between January and July of 2021, a period of rapid emergence of novel SARS-CoV-2 variants.

Brii said BRII-196 and BRII-198 are non-competing SARS-CoV-2 monoclonal neutralizing antibodies derived from convalesced COVID-19 patients. The mAbs were engineered to reduce the risk of antibody-dependent enhancement, enhance antibody penetration to the lung and prolong plasma half-life for more durable results. The company believes their non-overlapping epitope binding regions provide a high degree of neutralization activity against SARS-CoV-2.

Brii said it would release efficacy data by variant type, though in vitro testing shows the combination therapy is effective against all major groups.  

"Following on the heels of a positive Phase III data readout from the ACTIV-2 trial, and as countries around the world continue to face a significant resurgence of COVID-19 cases, we are doubling down on our efforts to bring BRII-196/BRII-198 to a broad range of patients as a promising potential new treatment option for COVID-19," said Zhi Hong, PhD, Chairman and CEO of Brii Biosciences. "This investment reinforces the company's mission, building on the highly effective clinical outcomes, as we accelerate our strategic efforts to pursue regulatory filings, expand manufacturing and supply capabilities and establish key collaborations in both established and emerging global markets to pave a clear and compelling path to commercialization."

Brii is a China-US company that is developing therapies for infectious diseases such as hepatitis B virus (HBV), human immunodeficiency virus (HIV), multi-drug resistant (MDR) or extensive drug resistant (XDR) gram-negative infections, along with other conditions that include central nervous system (CNS) diseases.

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Disclosure: none.