INDIANAPOLIS — Eli Lilly and Company said phase two of a clinical trial has shown a reduced rate of hospitalization for patients treated with a neutralizing antibody.
The data from the BLAZE-1 clinical trial evaluated LY-CoV555, a SARS-CoV-2 neutralizing antibody, for the treatment of symptomatic COVID-19 in the outpatient setting.
According to Lilly, the antibody is designed to block viral attachment and entry into human cells, which would neutralize the virus, potentially preventing and treating COVID-19.
The trial enrolled mild-to-moderate recently diagnosed COVID-19 patients across four groups receiving different doses (placebo, 700 mg, 2800 mg and 7000 mg).
Lilly reports most patients, including those receiving the placebo, demonstrated near complete viral clearance by day 11 of the trial.
The data showed 1.7 percent (5/302) of LY-CoV555 patients, pooled across all three dosage groups, were hospitalized as compared to 6 percent (9/150) of placebo patients, which corresponds to a 72 percent risk reduction in the limited population.
Lilly said most of the hospitalizations occurred in patients with underlying risk factors, suggesting a more pronounced treatment effect for patients in these higher-risk groups. Analysis indicated participants who received the antibody showed a more rapid improvement in symptoms than those who received the placebo, supporting the outcome of fewer hospitalizations in those patients.
"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," Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories, said in a press release. "The results reinforce our conviction that neutralizing antibodies can help in the fight against COVID-19."
Lilly said LY-CoV555 is well-tolerated. None of the participants have experienced drug-related serious adverse side effects in the study.
The BLAZE-1 clinical trial will continue testing LY-CoV555 in combination with a second Lilly antibody, LY-CoV016.
Thursday, Lilly announced a partnership with global manufacturing company Amgen to allow for an increased production of the antibodies if they prove to be effective. Skovronsky said the collaboration means the companies could produce "many millions of doses" of neutralizing antibodies as early as next year.