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Eli Lilly said on Thursday that her monoclonal antibody prevented Covid-19 infections among residents and staff of nursing homes in a clinical trial, the first time such treatment has been shown to prevent infection .
Lilly published the results in a press release, although she said she would release the data in a research paper as soon as possible.
In November, the antibody, bamlanivimab, was cleared for emergency use by the Food and Drug Administration in the treatment of patients with Covid who are at risk of more serious illness. A cocktail of antibodies produced by the biotechnology firm Regeneron has also been authorized.
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But Lilly believes her antibody could be an option not only to treat Covid-19, but also to help prevent it in limited circumstances.
“Of course, I think vaccines are more effective than prophylaxis and probably longer lasting,” Daniel Skovronsky, scientific director of Eli Lilly, said in an interview. “So this should in no way be seen as competition for vaccines. This should be the case when it is too late, when there is an epidemic and people are exposed and there will be no time for a vaccine to work.
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The study, which began on August 3, was conducted with the National Institute of Allergy and Infectious Diseases. Lilly used an unusual strategy: a fleet of refitted RVs that could prep study drug, do lab work, and pull trailers that could be used as on-site infusion clinics. This meant that when a nursing home or long-term care facility had an outbreak, an RV could be sent. Lilly developed the antibody in collaboration with Abcellera, a Vancouver-based biotechnology company.
Lilly enrolled 1,097 participants in the study. Of these, 132 tested positive for the SARS-CoV-2 virus, responsible for Covid-19, at the start of the study. Of the remaining participants, 300 were residents of long-term care facilities and the rest were facility staff, including health care workers.
Of these, 965 symptomatic Covid-19 infections were reduced by 57%. Among the 299 patients residing in a nursing home, the results were even stronger, reducing symptomatic cases of Covid-19 by 80%. In both cases, the result was statistically significant.
There were four deaths among the 965 patients, all in the placebo group. When the 132 who tested positive at the start of the study were included, there were four more deaths – again, only among patients who received a placebo. All of the deaths involved residents and not staff.
Among the 299 nursing home residents, there were four deaths attributed to Covid-19, all in the placebo arm. Among the 41 nursing home residents who tested positive at the start of the study, there were four deaths, still in the bamlanivimab arm.
In order to obtain a long duration of effect from the antibodies, Lilly used a dose of 4.2 grams, about six times the dose allowed for use in patients with Covid-19. Bamlanivimab is administered intravenously.
Covid-19 vaccines have already been made available to patients in nursing homes, Skovronsky admitted. But he said the antibodies could still come in handy if there were outbreaks in places where vaccines had not been reached. Eli Lilly will speak with the FDA to see if a new emergency clearance is warranted. Regeneron is conducting its own Covid prevention study in households where a member has been infected.
Skovronsky said he also hopes the results will encourage people who develop Covid to receive antibody treatment. The use of monoclonal antibodies has been more sporadic than expected, in part because of delivery issues and in part because doctors and patients don’t know how to ask for them. The government purchased large stocks of antibodies from both Lilly and Regeneron; that drugs are used more after governments have bought them makes no difference to companies.
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