Lilly launches phase III clinical trial of new coronavirus and antibody.

Like the new crown vaccine, antibody-based new crown drugs are advancing at an unprecedented rate.
antibody drugs have the potential to help prevent new coronavirus infections and treat COVID-19 in older people with poor vaccine response or in people with weakened immune systems.
while any benefits of vaccines and antibodies may be temporary, antibody drugs can work quickly, meaning they can prevent infection or worsen the condition in patients with new coronary pneumonia who have developed symptoms.
if proven in clinical trials, such antibody drugs would be a boon to the health care system, at least as a bridge to help patients transition to a safe and effective vaccine.
, however, it is unclear whether these antibody drugs will meet expectations.
No company has reported data on the effectiveness of human trials, although several drugmakers are rapidly advancing the development of new coronal antibody drugs, including Lilly, Regenerative, AbbVie, AstraZenecon and Vir Biotechnology.
have become industry-leading companies in antibody drug development.
, Regeneratives launched Phase III trials based on a retrospective analysis of safety data from a small study.
Lilly has now made a similar decision, launching a Phase III study after early tests found that its antibody drugs were "well-to-bear at all test doses."
According to a Lilly press release, the company has launched Phase III BLAZE-2 trials in the United States, which will be conducted with the help of the U.S. government, primarily among residents and staff of long-term care facilities (often in nursing homes and assisted living communities) who are at high risk of infection, to test whether the antibody LY-CoV555 can prevent new coronavirus infections and treat COVID-19.
, more than 40 percent of COVID-19 deaths in the United States are linked to outbreaks in long-term care facilities, according to an analysis by The New York Times.
LY-CoV555, developed by Lilly in collaboration with Canadian biotech company AbCellera, is a monoclonal antibody that has a strong effect on SARS-CoV-2 echithrin, isolated from blood samples collected by the first COVID-19 rehabilitation in the United States.
, drugmakers conduct research through experienced test sites, such as large medical centers, which have the tools and materials to conduct complex medical experiments.
for BLAZE-2, Lilly and the National Institutes of Health's COVID-19 Prevention Network (CoVPN) are using modified recreational vehicles (RVs) as on-site infusion clinics in nursing homes participating in the study.
with these RV fleets, Lilly aims to respond quickly to disease hotspots and recruit 2,400 nursing home residents or staff.
the trial will test whether a single dose of LY-CoV555 can reduce coronavirus infection rates within four weeks and COVID-19 complications within eight weeks.
Lilly has two other studies under way: a Phase I trial in hospitalized COVID-19 patients and a Phase II study of BLAZE-1 involving 400 patients, which was conducted in mild to moderate patients who were recently diagnosed with COVID-19.
is expected to complete the BLAZE-1 entry in September, after which preliminary results will be released shortly and full data will be available in the fourth quarter.
, Lilly has not yet provided a timetable for the BLAZE-2 trial.
said data disclosure for Phase II and Phase III trials was highly dependent on patient grouping.
said two other Phase III studies will be conducted on patients with COVID-19 who were hospitalized mildly, moderately or severely.
the company expects 100,000 doses of LY-CoV555 to be ready by the end of the year if the drug proves effective.
same time, Lilly's partner in China, Regency Bio, in June pushed another antibody drug, JS016, into human Phase I clinical trials.
JS016 is also an all-human monoclonal antibody that is rapidly screened from patients in rehab and recombined in vitro to express a high degree of virus-based and ability.
in preclinical in vitro and rhesus monkey trials, JS016 demonstrated good mesoactive and blocking capabilities, demonstrating the potential for treatment and prevention against the new coronavirus.
mid-July, Junshi Bio announced that all subjects in the China Phase I trial had completed the dosing and that dose-limiting events had not been observed to date.
as the first new coronavirus and antibody to enter the clinic in China, JS016 is at the leading global level in research and development, and its clinical trials in the United States were launched in the second quarter.
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