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Long-term care facilities will be the focus of Eli Lilly’s BLAZE-2 study for testing its LY-CoV555 antibody against SARS-CoV-2.
Eli Lilly recently announced the launch of its BLAZE-2 trial for LY-CoV555 in partnership with the National Institute of Allergy and Infectious Diseases for treating the novel coronavirus disease 2019 (COVID-19) in long-term care facilities.
LY-CoV555 is the company’s lead neutralizing antibody against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing COVID-19 infection, which stemmed from its earlier partnership with AbCellera. The IgG1 monoclonal antibody (mAb) is designed to block viral attachment and entry into human cells, and was first identified from a blood sample taken from 1 of the first US patients who recovered from COVID-19 illness.
The BLAZE-2 study is first of its kind in the COVID-19 arena, and Eli Lilly is not only collaborating with the National Institutes of Health, but also the COVID-19 Prevention Network, along with several long-term care facility networks in the United States.
Data suggest that up to 40% of COVID-19 related deaths in the United States are linked to long-term care facilities; Eli Lilly recognized the urgent need for therapeutic strategies to minimize the effect the virus is having on this vulnerable population.
BLAZE-2 is enrolling up to 2400 long-term care residents and staff who live or work at facilities that have reported COVID-19 cases, and therefore have a high risk of exposure to the virus. Investigators will test single doses of LY-CoV555 to look for reduced rates of SARS-CoV-2 infection through 4 weeks, and complications of COVID-19 through 8 weeks.
In order to effectively pursue the clinical trial within highly exposed facilities amid an unprecedented pandemic, Lilly created customized mobile research unit fleets with a retrofitted recreational vehicle that will function as mobile labs and locations to prepare materials, as well as trailer trucks that will deliver necessary supplies on-site.
Investigators with Lilly have completed dosing of LY-CoV555 in a phase 1 study, which evaluated hospitalized patients with COVID-19; long-term follow-up with these patients is ongoing. In addition, Lilly is dually pursuing the BLAZE-1 phase 2 study in which recently diagnosed patients in the ambulatory setting are being evaluated.
Lilly reported that LY-CoV555 was well-tolerated at all doses tested, with no severe adverse events yet observed. As the trial is ongoing, investigators have not found conclusive efficacy data.