Eli Lilly (NASDAQ: LLY) shared the latest results from a late-stage study which show its combination antibody COVID-19 treatment can reduce hospitalizations and deaths by an impressive 87 percent, compared with placebo.
The new data demonstrated that treatment with Lilly’s anti-SARS-CoV-2 neutralizing monoclonal antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) together reduced the risk of COVID-19 hospitalizations in over 750 high-risk patients recently diagnosed with the disease. The study is part of Lilly’s ongoing Phase III BLAZE-1 trial evaluating the antibody duo.
The study evaluated bamlanivimab at a dose of 700 mg along with 1,400 mg of etesevimab. In a previous study, Lilly’s antibody combo demonstrated a 70 percent reduction in hospitalizations and deaths at higher doses of 2,800 mg each.
The lower doses were recently authorized by the US Food and Drug Administration (FDA) for the treatment of COVID-19 patients aged 12 years and older who are at high risk for developing severe disease. The bamlanivimab and etesevimab combination therapy received emergency use authorization (EUA) from the agency in February. European regulators gave the treatment a nod in March.
These results provide additional efficacy and safety data to support the use of the currently authorized doses, as well as evidence for the efficacy of lower doses.
Bamlanivimab first received FDA authorization in November of last year as a standalone treatment for high-risk COVID-19 patients as a single dose 700 mg infusion. The antibody was developed in conjunction with Vancouver-based AbCellera.
This is the second large, late-stage study to show that combination therapy of two antibodies, bamlanivimab and etesevimab, is effective at treating mild to moderate cases of COVID-19.
Both antibodies bind to the receptor binding domain (RBD) of the spike protein on SARS-CoV-2 and are administered as intravenous (IV) infusions.
The new Phase III cohort of the BLAZE-1 trial involved 769 high-risk patients, aged 12 and older, with mild to moderate COVID-19. There were 511 patients in the treatment arm and 258 in the placebo group. An “event” was defined as hospitalization or death.
Among patients that received bamlanivimab with etesevimab, there were four events compared with 15 in patients given the placebo, amounting to an 87 percent reduction in risk.
High-risk patients for the treatment are classified as patients over the age of 65, or those under 65 who are overweight or have multiple health problems.
The bamlanivimab and etesevimab combination also yielded statistically significant improvements on key secondary endpoints. These results are consistent with the previous Phase III cohort of the higher 2,800 mg doses of the antibodies, as well as a Phase II cohort that showed bamlanivimab alone reduced the risk of hospitalizations and emergency room visits by about 70 percent. Reductions in viral loads were also consistent with those observed in the previous Phase III cohort.
In this new Phase III study, there were a total of four deaths which all occurred in the placebo group, and all of which were attributable to COVID-19. No deaths occurred in patients that were given bamlanivimab and etesevimab treatment. So far, across the two cohorts of the study, there have been no deaths in patients administered the combination therapy, while there have been 14 deaths in patients that received placebo, 13 of which were deemed COVID-19 related.
The safety profile of the bamlanivimab and etesevimab combination was consistent with that from other trials evaluating the antibodies.
“These positive results reinforce our previous findings and support the authorized dose of bamlanivimab 700 mg with etesevimab 1,400 mg. These compelling data give healthcare providers additional information regarding the use of bamlanivimab and etesevimab together as a potentially life-saving treatment to help those most at risk for severe complications of COVID-19,” said Daniel Skovronsky, MD, PhD, Lilly’s chief scientific officer and president of Lilly Research Laboratories, in a news release from the company.
“The consistent results observed in multiple cohorts of this trial over several months, even as new strains of COVID-19 have emerged, indicate bamlanivimab with etesevimab maintains its effects against a range of variants, particularly those circulating in the US.”
Skovronsky maintains that the antibodies are also effective against new SARS-CoV-2 variants.
“We are quite confident this combo covers all of the variants in the US,” he said. Skovronsky also added that Lilly is studying an additional treatment for new COVID-19 strains, including those first identified in South Africa and Brazil.
After the FDA authorization in February, the US agreed to purchase a minimum of 100,000 doses of the therapy.
Skovronsky said Lilly is prepared to manufacture 1 million doses of the combination therapy in the coming months and is also in talks to offer supplies of the treatment to governments around the world.
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