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

Eli Lilly has begun a Phase 3 trial testing whether an experimental antibody drug can prevent either coronavirus infections or COVID-19 in nursing home residents or staff who have been exposed to someone diagnosed with the disease.

The unusual trial, which will be conducted with the help of the U.S. government, is focusing on a population group that is at particularly high risk of infection or poor health outcomes from COVID-19. More than 40% of U.S. COVID-19 deaths are linked to outbreaks at assisted living facilities, the drugmaker said in a statement announcing the study.

Lilly is now the second company with an antibody-based coronavirus treatment in late-stage testing, joining Regeneron, which started a Phase 3 trial earlier last month. Antibody drugs are designed to both prevent infections and treat people who have become sick, which could make them critical tools in beating back the pandemic. But it's not yet clear how effective they actually are.

Just as coronavirus vaccine makers are moving at unprecedented speed, so too are the developers of antibody-based drugs for the virus.

The treatments could potentially help prevent infections or COVID-19 in people for whom vaccines may not work as well, like the elderly or those with weak immune systems. Though any benefit would be temporary, antibody drugs are meant to act fast, meaning they might keep someone who is infected or showing symptoms from getting worse. If proven in testing, they could be a boon to healthcare systems, at minimum as a bridge to a safe and effective vaccine.

It's unclear whether these drugs will meet such high hopes, however. Though a large group of drugmakers — Lilly, Regeneron, AbbVie, AstraZeneca, Vir Biotechnology and others — are moving quickly, none of them have reported effectiveness data from human trials.

That includes both Lilly and Regeneron, which have emerged as leading companies. Regeneron's initiation of a Phase 3 trial last month appeared based on a review of safety data from a small study. And Lilly seems to be making a similar decision, starting its own late-stage study after finding in earlier testing that its antibody drug was "well tolerated at all doses tested."

Effectiveness data aren't yet available, said the drugmaker, which is working with the Canadian biotech AbCellera.

For the Phase 3 study, dubbed BLAZE-2, Lilly is leaning on the National Institute of Health's COVID-19 Prevention Network, or CoVPN, to help run the unusual trial.

Typically, drugmakers run studies through experienced trial sites like major medical centers, which have the tools and materials to conduct complex medical experiments. For BLAZE-2, Lilly and the CoVPN are using retrofitted recreational vehicles as on-site infusion clinics at nursing homes involved in the study. Lilly will also send staff to each facility.

With this fleet of RVs, Lilly aims to quickly respond to disease hot spots and enroll as many as 2,400 nursing home residents or staff. The trial will test whether a single dose of the antibody drug can reduce the rate of coronavirus infection through four weeks and complications of COVID-19 through eight.

Lilly has two other studies underway: a Phase 1 trial in hospitalized COVID-19 patients and a 400-patient Phase 2 study, BLAZE-1, in people recently diagnosed with mild-to-moderate cases of COVID-19. Lilly expects to complete enrollment in BLAZE-1 in September, report initial results "soon thereafter" and have full data by the fourth quarter.

No timeline was provided fro BLAZE-2. A company spokesperson told BioPharma Dive that the data disclosures for the Phase 2 and Phase 3 trials are "highly dependent on patient enrollment."

Lilly has also said it will run two other Phase 3 studies in mild-to-moderate or severe, hospitalized COVID-19 patients. The company expects to have 100,000 doses of the drug ready by the end of the year, should it prove effective.

Its China-based partner Junshi Biosciences, meanwhile, separately advanced in June another antibody drug into human testing in that country.

Author:Ben Fidler


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