The late-stage clinical trials of the monoclonal antibody therapy (mAb) bamlanivimab (LYCoV555) for COVID-19 conducted by the US pharmaceutical company Eli Lilly has been recently halted by the health regulators over potential safety concerns.
LY-CoV555 developed by Eli Lilly and AbCellera is a potent, neutralising IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralising the virus, potentially preventing and treating COVID-19.
The ACTIV-3 trial had enrolled 326 mild to moderate COVID-19 patients who were administered with an intravenous infusion of the neutralising IgG1 mAb LY-CoV555 or placebo along with antiviral drug remdesivir in both the arms. The independent Data Safety Monitoring Board (DSMB) found that after five days of treatment, the group of patients who had received the antibodies showed a different “clinical status” than the group who had received a saline placebo — a difference that crossed a predetermined threshold for safety.
The trial is one of several that are part of the National Institute of Health’s “Activ” programme, which is designed to accelerate the development of novel coronavirus vaccines and treatments. It is backed by Operation Warp Speed, the Trump administration’s effort to manufacture and distribute novel coronavirus vaccines.
The treatment is similar to the one made by Regeneron that was given to President Donald Trump earlier this month after he tested positive for the novel coronavirus.
The decision by Eli Lilly comes just a day after Johnson & Johnson announced the pause of its coronavirus vaccine trial because of a sick volunteer, and a month after AstraZeneca’s vaccine trial was halted over concerns about two participants who had fallen ill after getting the company’s vaccine.
“Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board has recommended a pause in enrollment,” said Eli Lilly’s spokeswoman Molly McCully, in a statement.