Lilly Launches Phase 3 Clinical Trial of SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Nursing Homes

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Just like COVID-19 vaccines, antibody-based drugs for COVID-19 are advancing at an unprecedented pace. These antibody drugs have the potential to help prevent SARS-CoV-2 infection and treat COVID-19 in elderly populations or individuals with weakened immune systems who respond poorly to vaccines.

Although any benefits from vaccines and antibodies may be temporary, antibody drugs can act rapidly, meaning they can prevent infection or halt the progression of disease in COVID-19 patients who have already developed symptoms. If confirmed in clinical trials, such antibody drugs would be a boon to healthcare systems, serving at least as a bridge to help patients transition until safe and effective vaccines become available.

However, it remains unclear whether this class of antibody drugs can meet expectations. Although multiple pharmaceutical companies, including Eli Lilly, Regeneron, AbbVie, AstraZeneca, and Vir Biotechnology, are rapidly advancing the development of COVID-19 antibody therapeutics, none has yet reported efficacy data from human clinical trials.

In the field of antibody drug development, Eli Lilly and Regeneron have emerged as industry leaders. Last month, Regeneron initiated a Phase III trial based on a retrospective analysis of safety data from a small-scale study. Now, Eli Lilly has made a similar decision, launching its own Phase III study after early testing revealed that its antibody drug was “well-tolerated at all tested doses.”

According to a press release issued by Eli Lilly, the company has launched the Phase III BLAZE-2 trial in the United States. With assistance from the U.S. government, the trial will primarily enroll residents and staff of long-term care facilities (typically referring to nursing homes and assisted living communities)—populations at high risk of infection and with poor health status—to evaluate whether the neutralizing antibody LY-CoV555 can prevent SARS-CoV-2 infection and treat COVID-19. According to an analysis by The New York Times, more than 40% of COVID-19 deaths in the United States have been linked to outbreaks in long-term care facilities.

LY-CoV555, developed by Eli Lilly in collaboration with the Canadian biotechnology company AbCellera, is a monoclonal antibody isolated from blood samples collected from some of the first COVID-19 survivors in the United States. It exhibits potent neutralizing activity against the SARS-CoV-2 spike protein.

Typically, pharmaceutical manufacturers conduct research through experienced trial sites, such as large medical centers, which possess the tools and materials necessary for complex medical experiments. For BLAZE-2, Eli Lilly and the National Institutes of Health’s COVID-19 Prevention Network (CoVPN) are using modified recreational vehicles (RVs) as on-site infusion clinics at nursing homes participating in the study. With this fleet of RVs, Eli Lilly aims to rapidly respond to disease hotspots and enroll 2,400 nursing home residents or staff members. This trial will test whether a single dose of LY-CoV555 can reduce the rate of coronavirus infection within four weeks and decrease COVID-19 complications within eight weeks.

Eli Lilly has two additional studies underway: a Phase I trial in hospitalized COVID-19 patients, and the Phase II BLAZE-1 study involving 400 patients with recently diagnosed mild to moderate COVID-19. Eli Lilly expects to complete enrollment in BLAZE-1 by September, release preliminary results shortly thereafter, and obtain full data in the fourth quarter.

Currently, Eli Lilly has not provided a timeline for the BLAZE-2 trial. A company spokesperson stated that the disclosure of data from Phase II and Phase III trials is highly dependent on patient enrollment. Eli Lilly also announced that it will conduct two additional Phase III studies in patients with mild-to-moderate or severe hospitalized COVID-19. The company expects that, if the drug proves effective, 100,000 doses of LY-CoV555 will be ready by the end of this year.

Meanwhile, Junshi Biosciences, Eli Lilly’s partner in China, advanced another antibody drug, JS016, into Phase I clinical trials in June. JS016 is a fully human monoclonal antibody with potent viral neutralizing activity, rapidly screened from convalescent patients and recombinantly expressed in vitro. In preclinical in vitro studies and in vivo experiments in rhesus monkeys, JS016 demonstrated robust neutralizing activity and blocking efficacy, highlighting its therapeutic and prophylactic potential against SARS-CoV-2.

In mid-July, Junshi Biosciences announced that all participants in its Phase I clinical trial in China had completed dosing, with no dose-limiting toxicities observed to date. As the first domestically developed neutralizing antibody against SARS-CoV-2 to enter clinical trials in China, JS016’s development progress is at the forefront globally, and its clinical trials in the United States were also launched in the second quarter.

Reference Source:

1、Lilly starts phase 3 test of COVID-19 antibody in nursing homes

2、Lilly to test COVID-19 antibody drug in unorthodox nursing home study