Brii Biosciences has filed an emergency use authorization (EUA) application for its investigational SARS-CoV-2 monoclonal antibody combination therapy, BRII-196/BRII-198, to the US Food and Drug Administration (FDA).
Obtained from convalesced Covid-19 patients, BRII-196 and BRII-198 are non-competing monoclonal antibodies that neutralise SARS-CoV-2.
The new combination therapy is intended to treat non-hospitalised Covid-19 patients who are at high risk of clinical progression to severe disease.
The company stated that the EUA submission is based on the positive Phase III results obtained from the ACTIV-2 clinical trial, which was funded by the National Institutes of Health (NIH).
The trial was conducted at clinical trial sites worldwide that include Brazil, South Africa, Mexico, Argentina, the Philippines and the US.
The data obtained from the study demonstrated a statistically significant reduction of 78% relative risk of hospitalisation and death compared to placebo.
It has also showed improved safety and zero deaths by day 28 of the trial compared to eight deaths reported using the placebo.
Additionally, Brii Biosciences is planning to submit the clinical data supporting the EUA submission to the US FDA on a rolling basis.
Upon completion of the EUA submission, review and approval, the company plans to work with the regulatory agency to coordinate regarding the further steps to obtain full regulatory approval for BRII-196/BRII-198.
Brii Biosciences chairman and CEO said Zhi Hong said: “We are very pleased with the continued positive clinical outcomes and favourable safety profiles throughout the development of BRII-196/BRII-198 in this well designed and executed global clinical trial, and we intend to bring this potential new treatment option, supported by the strong clinical evidence, to a broad range of Covid-19 outpatients at high risk of clinical progression.
“If authorised for emergency use, we are well positioned to accelerate manufacturing of BRII-196/BRII-198 as quickly as possible in order to supply the ongoing demand for the treatment of non-hospitalised Covid-19 patients at high risk of clinical progression throughout the US.”
The company noted that it has also submitted investigational new drug (IND) applications to the Department of Health in Hong Kong, China, the China National Medical Products Administration (NMPA), and the US FDA for the combination BRII-196/BRII-198 and also received approvals.
It is also conducting additional studies in China to assess the pharmacokinetics and safety of combination BRII-196/BRII-198 for the treatment of Covid-19.