BRII 196 + BRII 198 combination filed with FDA for emergency use authorization in COVID-19.- Brii Biosciences

The EUA filing is based on positive results from the NIH-sponsored Phase III clinical trial, ACTIV-2, in which the BRII 196 + BRII 198 combination demonstrated a statistically significant 78% 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. 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.

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. Investigational New Drug (IND) applications have been submitted by the Company and approved for the combination therapy to the U.S. FDA, the China National Medical Products Administration (NMPA) and the Department of Health in Hong Kong, China. The Company is conducting additional studies in China, evaluating the pharmacokinetics and safety of combination BRII 196 + BRII 198 as well as a Phase II efficacy study of lower dose combination BRII 196 + BRII 198 for the treatment of COVID-19.