Brii Biosciences has filled an emergency use authorization (EUA) application with the US Food and Drug Administration (FDA) for its combination therapy, BRII-196/BRII-198, to treat Covid-19 patients.
BRII-196/BRII-198 is a SARS-CoV-2 neutralising monoclonal antibody combination therapy, which is intended to treat non-hospitalised Covid-19 patients at high risk of clinical progression to severe disease.
The EUA submission is based on the positive Phase III results obtained from the ACTIV-2 clinical trial that was announced in August.
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 showed that the combination therapy provided a 78% statistically significant decline of relative risk of hospitalisation and death compared to placebo.
It has also demonstrated that BRII-196/BRII-198 improved safety and zero deaths by day 28 of the trial in non-hospitalised Covid-19 patients.
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 the 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 stated that the clinical data to support the EUA submission is planned to be submitted to the US FDA on a rolling basis.
It also plans to work with the FDA to coordinate the next steps to obtain full regulatory approval for its combination therapy after the completion of the EUA submission, review and approval.
Additionally, Brii Biosciences has submitted investigational new drug applications to the China National Medical Products Administration (NMPA), the Department of Health in Hong Kong, China and the US FDA for the combination therapy and received approvals.