dm+d

Unassigned

New Medicines

Coronavirus disease 2019 (COVID-19) treatment - in combination with BRII-198 in ambulatory patients

Information

New molecular entity
Brii Biosciences
Brii Biosciences

Development and Regulatory status

None
None
Pre-registration (Filed)
Oct 21Brii Bio initiate Emergency Use Authorisation (EUA) application filing with FDA for treatment of non-hospitalised COVID-19 patients at high risk of clinical progression [6].

Category

BRII-196 and BRII-198 are neutralising monoclonal antibodies against SARS CoV-2 isolated from patients who have recovered from COVID-19. Block viral entry and neutralise live infection by binding to a epitope on the spike protein [1].
A novel coronavirus (Covid-19) was identified as the cause of pneumonia cases in Wuhan, China in November 2019 and declared by the WHO as a global pandemic in March 2020.
Coronavirus disease 2019 (COVID-19) treatment - in combination with BRII-198 in ambulatory patients
Intravenous infusion

Trial or other data

Aug 21Interim data from the ongoing PIII ACTIV-2 trial (NCT04518410) in the US, Central and S.America and the Philippines demonstrated relative risk reduction of 78% ([95% CI]: 0.22 [0.05, 0.86], p<0.00001 (nominal, one-sided) in the combined endpoint of hospitalisation (12 vs. 45 with placebo)and death (1 vs. 9 with placebo) in 837 non-hospitalised COVID-19 pts at high risk of clinical progression. Additional subgroup analysis may further delineate the clinical benefits of early (≤5 days) vs. late (6-10 days) treatment with BRII-196/BRII-198. Adverse events were less frequent among the BRII-196/BRII-198 arm (3.8%) vs. placebo (13.4%). The trial is still recruiting and has a primary completion date of Dec 23. [4,5]
Apr 21Brii Biosciences announce progression of the antibody cocktail of BRII-196 and BRII-198 to PIII in the ACTIV-2 trial for ambulatory patients with COVID-19 at high risk of progression to severe disease, as recommended by a DSMB composed of independent subject matter experts. The PIII portion of the study is expanding into international trial sites and is designed to determine if the combination BRII-196 and BRII-198 will prevent the composite endpoint of either hospitalisation or death through study day 28 [3].
Aug 20PII/III ACTIV-2 trial (NCT04518410), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), has started in the US. The adaptive study will investigate safety and efficacy of a number of drugs, both infused and non-infused in people (n=2000) who have tested positive for COVID-19 but who do not currently need hospitalisation. For infused agents, enrolment will be restricted to participants at higher risk of progression to severe COVID-19. Non-infused agents will be open to participants at both "higher" and "lower" risk of progression to severe COVID-19. A combination of BRII-196 and BRII-198 is one of the arms of the trial. The study begins with a PII evaluation, followed by a transition into a larger PIII evaluation for promising agents, and will measure duration of COVID-19 symptoms and quantification of SARS-CoV-2 RNA over 28 days. Estimated primary completion is May 23 [2].