ANDLi Lilly said on Thursday that her monoclonal antibody prevented Covid-19 infections in nursing home residents and staff in a clinical trial, the first time such treatment has been shown to prevent infections.
Lilly released the results in a press release, although it said it would publish the data in a research article as soon as possible.
In November, the antibody, bamlanivimab, was authorized for emergency use by the Food and Drug Administration to treat patients with Covid who are at risk for more serious illness. An antibody cocktail made by the biotechnology company Regeneron was also authorized.
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But Lilly believes that her antibody may be an option not only to treat Covid-19, but to help prevent it in limited circumstances.
“Of course, I think vaccines are more effective than prophylaxis and probably more durable,” said Daniel Skovronsky, Eli Lilly’s scientific director, in an interview. “So this should not be seen in any way as competition for vaccines. It must be for when it is too late, when there is an outbreak and people are being exposed and there is no time for the vaccine to work ”.
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The study, which started on August 3, was conducted with the National Institute of Allergy and Infectious Diseases. Lilly used an unusual strategy: a fleet of refurbished recreational vehicles that could prepare the study drug, do lab work and pull trailers that could be used as infusion clinics on site. This meant that when a home or long-term care facility had an outbreak, a trailer could be sent. Lilly developed the antibody in collaboration with Abcellera, a Vancouver biotechnology.
Lilly enrolled 1,097 participants in the study. Of these, 132 tested positive for the SARS-CoV-2 virus, which causes 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 professionals.
Among these, 965, symptomatic infections by Covid-19 were reduced by 57%. Among the 299 patients residing in nursing homes, 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 of them in the placebo group. When the 132 who tested positive at the start of the study were included, there were another four deaths – again, only among patients who received a placebo. All deaths occurred in residents, not employees.
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, again in the bamlanivimab arm.
To obtain a long-lasting effect of the antibodies, Lilly used a dose of 4.2 grams, about six times the dose authorized 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 acknowledged. But he said the antibodies could still be useful if there are outbreaks in places where the vaccines have not reached. Eli Lilly will discuss with the FDA whether 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 hoped the results would encourage people who developed Covid to receive antibody treatment. The use of monoclonal antibodies has been more sporadic than expected, partly due to distribution problems and partly because doctors and patients do not know how to order them. The government bought large stocks of antibodies from Lilly and Regeneron; The fact that the drugs are used more after governments buy them makes no difference to companies.