New Phase III efficacy data from Eli Lilly showed that a combination of two experimental neutralizing antibodies, bamlanivimab and etesevimab, met the primary endpoint of reduced hospitalizations and deaths from COVID-19.
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New Phase III efficacy data from Eli Lilly showed that a combination of two experimental neutralizing antibodies, bamlanivimab and etesevimab, met the primary endpoint of reduced hospitalizations and deaths from COVID-19.
The company also reported preliminary data from a separate trial showing that lower doses of the antibodies result in similar viral loads and pharmacodynamics/pharmacokinetics to higher doses. The combination is currently under U.S. Food and Drug Administration (FDA) review for an emergency use authorization (EUA) for mild to moderate COVID-19 in high-risk patients.
In the BLAZE-1 trial, about half of the 1,035 high-risk COVID-19 patients enrolled received 2,800 mgs each of bamlanivimab and etesevimab. Only 2.1% of patients in the treatment wound up requiring hospitalization, and none died. In the control arm, 7% died or required hospitalization. Eli Lilly said the combination also met secondary endpoints of reducing viral load and speeding up symptom resolution, although data has not been released.
Bamlanivimab was co-developed with antibody company AbCellera Biologics. According to Carl Hansen, AbCelleras’ CEO and President, “Together with the recent data reported from the BLAZE-2 trial, no COVID-19 deaths have been observed in these treatment arms in patients treated with bamlanivimab, either alone, or together with etesevimab.”
The decrease in hospitalizations is also consistent with earlier Phase II testing, said Daniel Skovronsky, Eli Lilly’s chief scientific officer and president of Lilly Research Laboratories.
The early data supporting lower dosing comes from Eli Lilly’s Blaze-4 trial, which will ultimately enroll about 1,000 symptomatic COVID-19 patients outside of hospitals. Patients have so far received 2,800 mgs each of bamlanivimab and etesevimab, 700 mg bamlanivimab and 1400 mg etesevimab, or placebo. The company said it will explore even lower doses through the trial. Altogether, over 4,000 patients have so far participated in various safety and efficacy trials of bamlanivimab alone or in combination with etesevimab.
Both bamlanivimab and etesevimab are neutralizing recombinant human IgG1 monoclonal antibodies, and both target the SARS-COV-2 spike protein receptor binding domain to prevent entry into human cells.
The U.S. government has purchased 950,000 doses of bamlanivimab, including 650,000 doses after the FDA issued the EUA in November. Bamlanivimab is used in patients 12 and older with mild to moderate COVID-19, and who do not require hospitalization. The antibody does not appear to improve outcomes for patients already hospitalized and may worsen outcomes for those on ventilators. Last week, Eli Lilly announced positive data from its BLAZE-2 trial of prophylactic bamlanivimab alone, showing it cut the risk of contracting symptomatic COVID-19 by 80% among residents and staff of long-term care facilities.
