Lilly releases latest data on conciliation antibody combination therapy! Submit an emergency use authorization request to the FDA.

On October 7, Lilly announced the latest advances in its anti-SARS-CoV-2 virus and antibody development program, including two combination therapies for LY-CoV555 and LY-CoV016 (JS016 introduced from Regency) for the latest in-phase data from the newly diagnosed BLAZE-1 study in patients with mild to moderate COVID-19.
BLAZE-1 Study (NCT04427501) was a randomized, double-blind, placebo-controlled, Phase II study that evaluated LY-CoV555 and LY-CoV016 compared to placebos for treatment With differences in efficacy and safety in outpatients with symptoms COVID-19, 800 patients with mild to moderate symptoms and positive COVID-19 samples tested positive for SARS-CoV-2 within 3 days of drug infusion.
the single-drug treatment queue for the study assessed the therapeutic effectiveness and safety of LY-CoV555 in three doses (700,2800,7000 mg), and the combined drug group assessed the therapeutic effectiveness and safety of LY-CoV555 (2800mg) and LY-CoV016 (2800 mg).
the placebo group were allowed to cross-dosage into all the subject groups after completing the various group studies.
end of the study was the change in THE SARS-CoV-2 virus load over the baseline on the 11th day.
other endpoints include the proportion of patients hospitalized for COVID-19, mortality within 29 days, safety, etc.
the end-of-term analysis, 112 people in the combined therapy group and 156 people in the placebo control group.
results showed that the LY-CoV555 plus LY-CoV016 combination therapy significantly reduced the viral load on the 11th day (p-0.011), reaching the main endpoint of the study.
combination therapy also reduced the level of viruses on day 3 (p.0.016) and day 7 (p.lt;0.001) (an earlier point in time during infection, when higher viral loads are usually observed).
the combination therapy also reached a preset clinical endpoint, including a time-weighted average change in the overall symptom score from day 1 to 11 compared to the baseline.
exploratory analysis showed that the proportion of patients with still high viral load on day 7 of the combined therapy group was lower than in the placebo control group (3% vs 20.8%, p.lt;0.0001).
the risk of COVID-19-related hospitalization and emergency treatment in the combined therapy group was lower than in the placebo control group (0.9% vs 5.8%), with a reduced risk of 84.5%.
the hypothesis of drug resistance has not been observed in patients currently receiving combination therapy.
therapy is well-to-do, no serious drug-related adverse events (SAEs) have occurred, and treatment-related emergency adverse events (TEAEs) are comparable to placebos.
plans to publish clinical data on LY-CoV555 monotherapy and LY-CoV555-LY-CoV016 combination therapies in peer-reviewed journals as soon as possible.
LY-CoV555 is an IgG1 monoclonal antibody developed by Lilly in collaboration with AbCellera for the treatment and prevention of COVID-19, which binds directly to SARS-CoV-2's prickly protein, blocking the virus from adhesion and entering human host cells, thus playing a role in meliaring the virus.
LY-CoV016 is a recombinant all-human monoclonal neutralizing antibody that Lilly obtains development rights outside of Greater China from Regenerative Creatures, binding SARS-CoV-2 surface prick protein culture domain with high affinity specificity, and effectively blocking the binding of the virus to the host cell surface binder ACE2.
point mutations are introduced in the Fc segment of the IgG1 antibody to eliminate effects such as antibody-dependent enhancement (ADE), antibody-dependent cell-mediated cytotoxicity (ADCC), and antibody-dependent cell phagocytosphagy (ADCP).
In terms of the production and supply of melium antibodies, for LY-CoV555 monotherapy, given the similar clinical effects of the three doses of LY-CoV555, Lilly basically confirmed that 700 mg would be the clinical treatment dose and expected to supply 1 million doses of 700mg of LY-CoV555 by 2020Q4, of which 100,000 doses were guaranteed in October.
Lilly expects to supply 50,000 doses of the combined therapy by 2020Q4, which will be amplified from 2021Q1 as capacity expands and cooperation with Amgen in antibody production begins.
Before fully demonstrating that the therapy could be a clinically significant therapeutic option for COVID-19, Lilly's decision to invest heavily in amplifying antibody capacity also took on significant commercial risks, but it was also a social responsibility of pharmaceutical companies to meet global treatment needs.
In light of the positive data on combination therapies in the BLAZE-1 study and the previous data on LY-CoV555 monodrings, Lilly has been in close communication with regulators around the world and has formally submitted an application to the FDA for emergency use authorization (EUA) for the use of LY-CoV555 monodruditre therapies for high-risk newly diagnosed mild to moderate COVID-19 patients.
plans to file an EUA application for LY-CoV555 plus LY-CoV016 combination therapy with the FDA in November after obtaining additional safety data and capacity support.
expects 2021Q2 to have clinical data to support its formal listing application (BLA) with the FDA.
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