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Eli Lilly and Company announced interim proof-of-concept data from its BLAZE-1 Phase II clinical trial of LY-COV555, its neutralizing antibody therapy for COVID-19. The study enrolled mild-to-moderate COVID-19 patients who had recently been diagnosed in the outpatient setting and received either placebo, 700 mg, 2800 mg and 7000 mg of the antibody.
The primary endpoint of the trial is change from baseline in viral load at day 11. The 2800 mg dose level hit the primary endpoint, but the others did not. However, most patients—including those in the placebo group—almost completely cleared the virus by day 11. Analysis of the data showed that the antibody, LY-COV555, improved viral clearance around the third day, which was earlier than the controls, and decreased the proportion of patients who had persistently high viral loads at other periods.
“These interim data from the BLAZE-1 trial suggest that LY-CoV555, an antibody specifically directed against SARS-CoV-2, has a direct antiviral effect and may reduce COVID-related hospitalizations,” said Daniel Skovronsky, Lilly’s chief scientific officer and president of Lilly Research Laboratories. “The results reinforce our conviction that neutralizing antibodies can help in the fight against COVID-19.”
The biomarker data from the study, so far, correlated with the antibody’s positive impact on a prespecified endpoint of COVID-19-related hospitalization or emergency room visit. The endpoint was hit in 1.7% of patients receiving the antibody, pooled across all doses, compared to 6% in the placebo cohort. That comes to a 72% risk reduction in this particular limited population.
The company notes that most hospitalized patients in the study were in people with underlying risk factors, such as age or BMI, “suggesting a more pronounced treatment effect for patients in these higher-risk groups.”
No patients in the study, including on the placebo, progressed to mechanical ventilation or died. The bottom line appears to be indications patients receiving the antibody have a faster improvement in symptoms compared to placebo.
It was well-tolerated with no serious adverse events reported.
LY-CoV555 is a potent, neutralizing IgG1 monoclonal antibody directed against the spike “S” protein on SARS-CoV-2, the virus that causes COVID-19. The antibody came out of a collaboration between Lilly and AbCellera.
The company has successfully completed enrollment and primary safety assessments of the antibody in a Phase I trial of hospitalized COVID-19 patients and currently long-term follow-up is ongoing. A Phase II trial of individuals recently diagnosed in the ambulatory setting is ongoing. The company plans to launch a Phase III trial for prevention of COVID-19 in residents and staff at long-term care facilities. It is also being evaluated in the National Institutes of Health-led ACTIV-2 and ACTIV-3 studies of ambulatory and hospitalized COVID-19 patients.
Another big pharma company expecting results for a COVID-19 antibody trial is Regeneron Pharmaceuticals, which with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), launched Phase III trials of REGN-COV2, a two-antibody cocktail, in July. They are expecting key data sometime this month. The two trials include a Phase III trial of the cocktail to prevent infection in uninfected individuals who have had close exposure to a COVID-19 patient, and a Phase II/III portion of two adaptive Phase I/II/III trials in hospitalized and non-hospitalized COVID-19 patients.
Therapeutic antibodies are unlikely to be cures or to replace any vaccine that gets developed but are generally viewed as a stopgap measure while a vaccine is developed and approved. The effects of a therapeutic antibody typically last a few months and may be particularly helpful in individuals such as the elderly and immuno-compromised who do not respond as well to vaccines.