Eli Lilly's antibody treatment offers little benefit to people hospitalized with COVID-19, according to the National Institute of Allergy and Infectious Disease.
The NIAID ended Lilly's Phase 3 trial early, delivering a setback for the promising treatment. Lilly remains hopeful the treatment will prove beneficial to patients earlier in the disease's progression. That research remains ongoing.
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The halted trial, known as ACTIV-3, was studying the safety and efficacy of an intravenous infusion of bamlanivimab, Lilly's antibody therapy, in combination with remdesivir.
"While there was insufficient evidence that bamlanivimab improved clinical outcomes when added to other treatments in hospitalized patients with COVID-19, we remain confident based on data from Lilly's BlAZE-1 study that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19," the company said in a statement.
The monoclonal antibody is synthetically made to strengthen the immune system's response to the coronavirus. It is similar to the Regeneron therapy President Donald Trump received earlier this month.
Just two weeks ago, independent monitors had paused enrollment in the trial due to a possible safety concern. A safety issue with the therapy was never confirmed, but the NIAID said that initial data shows it is very unlikely to prove effective in patients who are already hospitalized with the infection.
Other studies on bamlanivimab continue, but they focus on the prevention of severe illness and hospitalization in patients with mild to moderate COVID-19.
Both Lilly and Regeneron have asked the U.S. Food and Drug Administration for emergency use authorization for their COVID-19 antibody treatments while research continues.
Lilly's request is based on the preliminary positive results shown in patients with mild to moderate infections in a separate Phase 2 trial. When given early enough, the drug appears to reduce the likelihood of requiring hospitalization.