Eli Lilly’s Antibody Cocktail Shines in Phase 3 Study, Significantly Reduces COVID-19 Deaths

Eli Lilly and Co. announced on March 10th that its combination antibody therapy of bamlanivimab and etesevimab reduced COVID-19 hospitalization risks and deaths by 87% in the Phase 3 BLAZE-1 study. The combination therapy was deemed effective at treating mild to moderate cases of COVID-19, the disease which by now has affected over 117 million people and claimed 2.6 million lives globally.

In their previous study published in January, a higher dose of the cocktail antibody reduced hospitalizations by approximately 70%. Additionally, a separate Phase 2 study showed similar effects from lower doses of bamlanivimab (700 mg) and etesevimab (1400 mg). This prompted the US Food and Drug Administration (FDA) to give emergency use authorization to the antibody cocktail in February and approved shorter infusion times for the combo and for bamlanivimab alone, while European regulators green-lighted the cocktail’s use in March.

“These positive results reinforce our previous findings and support the authorized dose of bamlanivimab 700 mg with etesevimab 1400 mg. These compelling data – in addition to the recent EUA from FDA, the CHMP decision from EMA, and the recommendation for the therapy in the National Institutes of Health’s COVID-19 Treatment Guidelines – 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, M.D., Ph.D., Chief Scientific Officer and President of Lilly Research Laboratories.

Lilly has agreed to sell 100,000 doses of the antibody cocktail to the US government for $210 million and has already supplied a million doses of bamlanivimab alone. The remaining doses are to be delivered before March-end, with the government having the option to purchase a further 1.1 million more doses. To achieve their goals, Lilly has partnered with Amgen in order to scale up its supply.

BLAZE-1 Trial

The new Phase 3 group of BLAZE-1 consisted of 769 patients aged 12 and older with mild to moderate COVID-19 and divided into 2 groups – the combination therapy group and placebo group. Data obtained from this study showed that the antibody cocktail met secondary endpoints, and only four events in patients were observed as compared to the fifteen events in the placebo group. The study encountered four deaths, all of which were in the placebo group. Additionally, the results were deemed consistent with the previous arm of the BLAZE-1 trial, along with the safety profile of the drugs involved.

“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 U.S.” Dr. Skovronsky added.

Road Ahead for Lilly

COVID-19 antibodies, although hailed as the next gamechanger in this pandemic, have been overlooked due to ramping up of vaccine production in recent months. With three vaccines approved in the last 3 months, antibody uptake hasn’t been as strong as expected, although data exists to show their effectiveness. This slow uptake has been partially linked to logistical issues, among many other underlying factors.

Lilly’s key competitor in this field, Regeneron, has already struck a massive deal worth $2.6 billion for over a million doses of its antibody combination called Regen-CoV. However, the fourth-quarter sales of Lilly’s bamlanivimab raked $871 million compared to Regen-CoV’s $146 million. Lilly anticipates collecting $1-$2 billion in revenues for their COVID-19 therapies in 2021 and has inked a deal with GlaxoSmithKline and Vir Biotechnology for bamlanivimab to be tested in a trial with GSK/Vir’s VIR-7831.

Related Article: COVID-19: FDA Grants Emergency Use Authorization for Eli Lilly’s Antibody Combo Therapy

Author

Tulip Chakraborty