Brii Biosciences has filed an emergency use authorisation (EUA) application for its investigational SARS-CoV-2 combination therapy, BRII-196/BRII-198, with the US FDA.
Data to support the EUA filing will be submitted on a rolling basis.
The filing is based on positive results from the NIH-sponsored Phase 3 clinical trial, ACTIV-2. In the trial, BRII-196/BRII-198 combination demonstrated a statistically significant 78% reduction of hospitalisation and death and improved safety over placebo in non-hospitalised COVID-19 patients at high risk of clinical progression to severe disease.
Similar efficacy rates were observed in participants initiating therapy early (0-5 days) and late (6-10 days), following symptom onset.
This analysis also showed zero deaths in the treatment arm versus eight deaths in the placebo arm through day 28. There was one death in each arm during the post 28-day follow up.
Following completion of the EUA submission, review and approval, Brii Bio plans to work closely with the FDA to coordinate on the next steps for full regulatory approval of combination BRII-196/BRII-198.
Zhi Hong, Chairman and CEO of Brii Bio, said: “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.”
In addition, the company is pursuing additional efforts and regulatory filings for combination BRII-196/BRII-198 in established and emerging markets with an initial focus on securing access in countries where clinical trials were conducted and where significant gaps in access to highly effective treatments have been identified.