Eli Lilly’s COVID-19 Antibodies Reduce Hospitalizations by 70%
The combination of the COVID-19 antibodies also improved all key secondary endpoints, including reducing viral loads and enhancing symptom resolution, the company reported.
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By - Eli Lilly and Company recently announced that its COVID-19 neutralizing antibodies reduced coronavirus-related hospitalizations and deaths in high-risk patients by 70 percent in a Phase 3 study.
Patients received 2,800 milligrams of bamlanivimab (LY-CoV555) and 2,800 milligrams of etesevimab (LY-CoV016) together. The drug combination demonstrated statistically significant improvement on all key secondary endpoints, reduced viral load, and boosted symptom resolution.
Additionally, across 1,035 patients in the BLAZE-1 trial, there were only 11 adverse events in patients taking the therapy and 36 events in patients taking the placebo. Notably, the reported 10 deaths in the study all took place in the placebo group.
"While the preliminary nature of Phase 2 results from COVID-19 neutralizing monoclonal antibodies may have limited acceptance of treatment, these Phase 3 data further strengthen the available evidence," Daniel Skovronsky, MD, PhD, Eli Lilly and Company’s chief scientific officer and president of Lilly Research Laboratories, said in the announcement.
“The 70 percent decrease in risk of hospitalizations or death seen in this Phase 3 trial of bamlanivimab and etesevimab together is consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone in the Phase 2 trial,” Skovronsky added.
Bamlanivimab was the first investigational medicine produced from the partnership between Eli Lilly and AbCellera. It was developed in three months after AbCellera and the Vaccine Research Center at NIAID identified it from a blood sample taken from one of the first US patients who recovered from COVID-19.
Across various clinical trials, Eli Lilly and Company has collected safety and efficacy data in more than 4,000 participants treated with either bamlanivimab alone or bamlanivimab and etesevimab together.
In the BLAZE-1 trial, the antibody combination proved consistent with results from other Phase 1, Phase 2, and Phase 3 trials evaluating these antibodies, Eli Lilly and Company highlighted.
For example, a JAMA Network Open study released last week found that, among non-hospitalized patients with mild to moderate coronavirus, treatment with bamlanivimab and etesevimab was associated with a statistically significant reduction in COVID-19 viral load at Day 11.
COVID-19 antibody treatments hold promise as effective countermeasures against the coronavirus, and experts have been actively looking to pursue these treatments as a complementary tool to fight COVID-19.
In August, Eli Lilly and Company initiated the Phase 3 BLAZE-2 trial studying bamlanivimab in residents and staff at nursing facilities across the US.
The study will evaluate the safety and efficacy of a single dose bamlanivimab in a total of 2,500 participants from facilities that have had a recently diagnosed case of COVID-19 and are at a high risk of exposure to the coronavirus.
Additionally, the study will uncover if the antibody reduces the rate of COVID-19 over four weeks and complications of the virus through eight weeks.
FDA issued emergency use authorization for bamlanivimab in infected patients 12 years of age or older in November 2020 after the Phase 2 BLAZE-1 trial found that all 465 COVID-19 patients showed reduced viral load and rates of symptoms and hospitalizations.
"The death toll from COVID-19 continues to rise around the world and hospitalizations, particularly in the US, have reached record highs,” Skovronsky said in the recent announcement.
“These data further support our belief that bamlanivimab and etesevimab together have the potential to be an important treatment that significantly reduces hospitalizations and death in high-risk COVID-19 patients,” he continued.
Eli Lilly and Company noted that initial results from the ongoing BLAZE-4 trial provide viral load and pharmacokinetic data, which demonstrated that 700 milligrams of bamlanivimab and 1,400 milligrams of etesevimab together are similar to 2,800 milligrams of bamlanivimab and 2,800 milligrams etesevimab together.
The company will explore even lower doses of the drug combination to maximize available supply to treat more patients.
