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Today, Eli Lily and Company announced the concept validation data obtained in the mid-term analysis of the BLAZE-1 clinical trial of the new coronavirus and antibody LY-CoV555, developed jointly with AbCellera.
the efficacy and safety of LY-CoV555, a randomized double-blind, placebo-controlled Phase 2 clinical trial, in outpatient treatment of patients with symptoms of COVID-19.
data show that treatment with LY-CoV555 is associated with lower hospitalization rates.
LY-CoV555 is a powerfully mediumed monoclonal antibody of IgG1 for the new coronavirus prickly protein.
it can prevent the virus from attaching and entering human cells, thus saling the virus and possibly preventing and treating COVID-19.
LY-CoV555 was found and developed from blood samples from the first COVID-19 rehabilitation patients in the United States.
in the BLAZE-1 clinical trial, recently diagnosed patients with mild and moderate COVID-19 were treated with placebos and different doses of LY-CoV555 antibodies (doses of 700 mg, 2800 mg and 7000 mg, respectively).
the main endpoint of the test was a change in the viral load compared to the baseline on the 11th day of treatment.
analysis showed that the 2800 mg group reached this primary endpoint, while the other dosage groups did not reach this main endpoint.
note that most patients, including those treated with a placebo, are nearing completion of the virus removal on the 11th day.
further analysis of the virus data showed that LY-CoV555 improved virus removal at an earlier point in time (day 3) and reduced the proportion of patients with sustained high viral load at subsequent points in time.
these biomarker data are associated with the intended endpoint of COVID-19-related hospitalizations or emergencies.
data from all dosage groups, 1.7% (5/302) of patients treated with LY-CoV555 needed hospitalization or emergency treatment.
the placebo group was 6 percent (9/150), which equates to a 72 percent reduction in risk in this limited number of people.
most hospitalized patients carry potential risk factors (age or body mass index), which means LY-CoV555 may have a more visible therapeutic effect on these high-risk groups.
ongoing research will try to confirm the findings.
in all treatment groups, including the placebo group, no patient progressed to mechanical aeration or died.
analysis showed that patients treated with LY-CoV555 showed faster improvement in symptoms.
LY-CoV555 is well-to-do and no serious adverse drug-related events are reported.
RNA sequencing showed that the risk of potential LY-CoV555 drug-resistant mutations was 8 percent in the treatment group and 6 percent in the placebo group.
plans to quickly publish the results of the interim analysis in peer-reviewed journals and discuss appropriate next steps with regulators around the world.
BLAZE-1 clinical trial is still in the works and will test the effects of LY-CoV555 in association with the second Lilly antibody, LY-CoV016.
LY-CoV016 is combined with different antigen progestins of the new coronavirus hedgehog protein.
the trial is currently recruiting a 3 dlist of high-risk patients to test the ability of antibody combinations to reduce the number of patients with sustained high viral loads and to reduce COVID-19-related hospitalizations.
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