Lilly says the new coronavirus combination therapy with antibodies is the main endpoint.

On October 8th Regency announced that its global partner, Eli Lilly and Company, had released positive in-period data for the treatment of newly diagnosed patients with mild and moderate coronary pneumonia (COVID-19) in combination with antibodies JS016 (LY-CoV016) and LY-CoV555.
plans to apply for the combined therapy's Emergency Use Authorization (EUA) in patients with mild to moderate new coronary pneumonia in November 2020.
JS016 is a recombinant all-human monoclonal neutralizing antibody that binds to the SARS-CoV-2 surface prick protein binding domain with high affinity specificity, and effectively blocks the binding of the virus to the host cell surface subject ACE2.
team introduced point mutations in natural human IgG1 antibodies to remove adverse effects such as tissue damage.
a new coronavirus attack test conducted in rhesus monkeys showed that JS016 had good results in preventing and treating new coronavirus infections.
at the beginning of the outbreak, Junshi Bio joined forces with the Institute of Microbiology (IMCAS) of the Chinese Academy of Sciences to fight the disease and jointly develop new coronary and antibodies.
, Lilly introduced JS016 from Regency Bio, which led development activities in Greater China and Lilly led development activities in other parts of the world.
LY-CoV555 is a powerful, neutral IgG1 monoclonal antibody against SARS-CoV-2 prickly proteins.
its research and development aims to prevent the virus from attaching to and entering human cells, thereby astration of the virus and potentially preventing and treating new coronary pneumonia.
LY-CoV555 comes from a research collaboration between Lilly and AbCellera to develop antibody therapies to prevent and treat new coronary pneumonia.
recent BLAZE-1 clinical trial, initiated by Lilly, released the latest in-phase analysis data.
results showed that a combination of two new coronavirus and antibodies reduced viral load, reduced symptoms, and reduced hospitalization and emergency visits associated with neo crown pneumonia.
the randomized, double-blind, placebo-controlled Phase 2 study was designed to evaluate the efficacy and safety of JS016 (LY-CoV016) in a joint LY-CoV555 treatment for patients with new coronary pneumonia with symptoms of infection.
the regions where the two meso-antibodies bind to the new coronavirus pyrethroid protein complement each other.
combination therapy cohort included newly diagnosed patients with mild to moderate neocyctic pneumonia and assigned to the combined treatment group (2800 mg per antibody) (n=112) or the placebo group (n=156).
combined therapy significantly reduced the viral load on the 11th day (p-0.011), reaching the main endpoint of the study.
patients, including those receiving a placebo, showed that the virus was almost completely cleared on the 11th day.
addition, combined therapy reduced virus levels on days 3 (p-0.016) and 7 (p-lt;0.001), usually during infection, higher viral loads were observed at earlier points in time.
from day 1 to day 11, combined therapy also significantly reduced the time-weighted average change over baseline.
analysis showed that the proportion of patients with high viral load on the seventh day of the combined treatment group (3.0%) was lower than in the placebo group (20.8%).
, no potential drug resistance mutations have been observed in patients receiving combined therapy.
same time, the combined treatment reached a preset clinical endpoint, including a weighted average change in the overall symptom scoring time from day 1 to day 11 compared to the baseline (p-0.009).
symptoms improved as early as 3 days after the drug was given.
hospitalization and emergency care rates (0.9%) were lower than those in the placebo group (5.8%) and the relative risk was reduced by 84.5% (p s 0.049).
of drug-related adverse events (SAEs) due to good tolerance to co-treatment.
drug-related infusion reactions or hypersensitive reactions distributed in LY-CoV555 monodration studies were usually mild (2 cases were reported as severe infusion reactions, all patients recovered).
adverse events (TEAE) in LY-CoV555 monotherapy, JS016 (LY-CoV016) and LY-CoV555 combination therapy were comparable to placebos.
press release, Lilly plans to publish the results of this issue in peer-reviewed journals as soon as possible.
At the same time, the BLAZE-1 clinical trial is continuing to include a confirmed queue of patients at higher risk of newly diagnosed mild and moderate neo-coronary pneumonia to assess the benefits of antibody combinations in reducing the number of patients with sustained high viral loads and reducing the risk of hospitalization associated with neocyclone.
, Lilly will explore low-dose combined therapy and alternatives to drug use in planned or ongoing clinical trials.
it's worth noting that Lilly has approached regulators around the world, including the FDA, about potential emergency use authorizations based on combination therapy data and previously disclosed LY-CoV555 single-drug treatment results.
company expects to submit an EUA application for JS016 and LY-CoV555 combination therapies in November 2020 after obtaining additional safety data and adequate production availability.
expects to obtain data and submit a Biopharmaceons License Application (BLA) for combined therapy as early as the second quarter of 2021.
Lilly's communications with regulators around the world are ongoing.
In China, Junshi Bio has completed phase 1 research to assess JS016 safety, tolerance, pharmacogenetic characteristics and immunogenicity among healthy subjects in China, and is conducting an international multi-center phase 1b/2 clinical study on patients with neo-corona pneumonia.
also plans to conduct a recent study on the prevention effects of JS016 in people at high risk of infection.
has successfully completed a similar JS016 Phase 1 clinical study among U.S. health subjects.
so far, JS016 has been well-to-do and no drug-related severe adverse events (SAEs) have been observed.
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