29 October 2020 - - The New England Journal of Medicine has published data from the monotherapy arms of BLAZE-1, a Phase 2 study assessing the efficacy and safety of US-based pharmaceutical company Eli Lilly and company's (NYSE: LLY) bamlanivimab (LY-CoV555) a neutralizing antibody in the COVID-19 outpatient setting, the company said.

This study focused on ambulatory COVID-19 patients being treated in the outpatient setting, whose symptoms did not require hospitalization at the time of enrollment.

The publication, which can be found here, follows Lilly's proof-of-concept data announcement for bamlanivimab as monotherapy in September 2020.

These data were submitted as part of Lilly's request for an emergency use authorization from the US Food and Drug Administration for bamlanivimab in higher-risk patients who have been recently diagnosed with mild to moderate COVID-19.

BLAZE-1 (NCT04427501) is a randomized, double-blind, placebo-controlled Phase 2 study designed to assess the efficacy and safety of bamlanivimab alone or in combination with a second antibody for the treatment of symptomatic COVID-19 in the outpatient setting.

To be eligible, patients were required to have mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than three days prior to drug infusion.

The monotherapy arms of the trial enrolled mild to moderate recently diagnosed COVID-19 patients, studying three doses of bamlanivimab (700 mg, 2800 mg, and 7000 mg) versus placebo.

The primary outcome measure for the completed arms of the BLAZE-1 trial was change from baseline to day 11 in SARS-CoV-2 viral load.

Additional endpoints include the percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through day 29, as well as safety.

The study is ongoing with additional treatment arms. Across all treatment arms, the trial will enroll over 800 participants.

Data from the BLAZE-1 study show bamlanivimab may be effective in treating COVID-19 by reducing viral load, symptoms and the risk of hospitalization in patients recently diagnosed with mild to moderate COVID-19.

In the BLAZE-1 trial, rates and types of adverse events were similar between bamlanivimab and placebo, with the majority being mild to moderate in severity and with no drug-related serious adverse events reported thus far.

In other bamlanivimab studies, there have been isolated drug-related infusion reactions or hypersensitivity that were generally mild (two reported as serious infusion reactions, both patients recovered).

LY-CoV555 is a potent, neutralizing IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing and treating COVID-19.

LY-CoV555 emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19.

Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.

It was identified from a blood sample taken from one of the first US patients who recovered from COVID-19.

Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing.

A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing.

In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study of ambulatory COVID-19 patients.

Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world.

Existing Lilly medicines are now being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with partner companies to discover novel antibody treatments for COVID-19.

Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19. Click here for media resources related to Lilly's COVID-19 efforts.