Eli Lilly has initiated a phase 3 trial of its monoclonal antibody (mAb) LY-CoV555 for the prevention of the novel coronavirus in nursing homes across the US.
The BLAZE-2 study is being conducted in partnership with the US National Institute of Allergy and Infectious Disease (NIAID) and will evaluate the safety and efficacy of LY-CoV555 for the prevention of SARS-CoV-2, the virus which causes COVID-19.
The study will enrol up to 2,400 residents and staff who live or work at long-term care facilities in the US that have had a recently diagnosed case of COVID-19, and who are now at a high risk of exposure to the virus.
Participants will be given one dose of LY-CoV555, and will be monitored while researchers determine its ability to reduce infection rates and treat those who have already been infected with the virus.
“COVID-19 has had a devastating impact on nursing home residents. We’re working as fast as we can to create medicines that might stop the spread of the virus to these vulnerable individuals,” said Daniel Skovronsky, chief scientific officer of Lilly and president of Lilly Research Laboratories.
“While it’s not easy to conduct clinical trials in this setting, we’re taking on the challenge in an effort to help those who need us the most,” he added.
To expedite the study, Lilly has created mobile research units to support the on-site aspects of the investigation. This includes custom retrofitted recreational vehicles (RV) that will support mobile labs and clinical trial material preparation.
The mAb is being developed in collaboration with AbCellera, following a co-development agreement signed in March for COVID-19 treatments.
When the two companies entered the partnership, AbCellera identified 500 fully human antibody sequences after receiving a blood sample from a recovered COVID-19 patients.
LY-CoV555 is the result of this early screening, and is now the lead candidate from Lilly’s collaboration with AbCellera.
Lilly has already completed dosing of the mAb in a phase 1 study of hospitalised patients with COVID-19, with long-term follow-up ongoing.
Another phase 2 study, BLAZE-1, in people recently diagnosed with COVID-19 in the ambulatory setting is also ongoing – Lilly estimates that enrolment will be completed in September, with an initial data readout expected soon after that.
If the drug proves effective in these trials, Lilly hopes to manufacture and make available over 100,000 doses by the end of the year.
A number of antibodies are currently being investigated for efficacy against COVID-19, including Regeneron’s double antibody cocktail REGN-COV2.
Regeneron is testing the drug in hospitalised and non-hospitalised COVID-19 patients, and also as a prevention treatment against the virus.