Phase III BLAZE-1 trial shows combination of monoclonal antibodies bamlanivimab and etesevimab reduces risk of hospitalization and death in high-risk patients with newly diagnosed COVID-19

In the study (n=769), where treatments were administered in outpatient setting and early in course of disease, there were 4 four events (hospitalisation or death from any cause by day 29) in the bamlanivimab with etesevimab arm vs. 15 events in placebo arm (p<0.0001).

SPS commentary:

Bamlanivimab directs itself against the spike protein SARS-CoV-2 to block viral attachment and entry into human cells. Etesevimab specifically binds to the surface spike protein receptor domain on SARS-CoV-2 to block binding of the to the ACE2 host cell surface receptor.

According to the company, the new findings from the BLAZE-1 trial offer additional safety and efficacy data to support the use of the studied dose recently granted EUA by the FDA. Additionally, the studied dose was also given a positive scientific opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), which has started a ‘rolling review’ of data on these antibodies.

Biospace Inc.

Resource links:

EMA rolling review