ELi Lilly said Thursday that his monoclonal antibody Covid-19 infections occur in residents and nursing home staff in a clinical trial. This is the first time that such a treatment can prevent infection.
Lilly released the results in a press release, though she said she would publish the data in a research article as soon as possible.
In November, the antibody, bamlanivimab, was approved by the Food and Drug Administration for emergencies in the treatment of patients with Covid who are at risk of becoming more serious. An antibody cocktail made by the biotechnology firm Regeneron was also approved.
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But Lilly believes his antibody can not only be an option to treat Covid-19, but also to prevent it in limited circumstances.
“Of course I think the vaccines are more effective than prophylaxis and probably longer,” Daniel Skovronsky, chief scientific officer of Eli Lilly, said in an interview. ‘It should therefore in no way be seen as competition against vaccines. It should be when it is too late, when there is an outbreak and people are exposed and there is 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 converted recreational vehicles that could prepare study medicine, do laboratory work, and tow trailers that could be used as infusion clinics on site. 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 biotechnology company in Vancouver.
Lilly enrolled 1,097 participants in the study. Of these, 132 were tested positive for the SARS-CoV-2 virus, which causes Covid-19, at the beginning of the study. Of the remaining participants, 300 were residents of long-term care facilities and the rest were facility staff, including health workers.
Among them, 965, symptomatic Covid-19 infections were reduced by 57%. Among the 299 patients who were in nursing homes, the results were still stronger, reducing the symptomatic Covid-19 cases 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 admitted, there were four more deaths, just again among patients receiving placebo. All deaths were with residents, 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, again in the arm of bamlanivimab.
To obtain a long-lasting effect of the antibodies, Lilly used a dose of 4.2 grams, approximately six times the dose allowed for use in patients with Covid-19. Bamlanivimab is administered intravenously.
Skovronsky acknowledged that Covid-19 vaccines have already been made available to patients in nursing homes. But he said the antibodies could still be useful if there were outbreaks in places that did not reach the vaccines. Eli Lilly will discuss with the FDA whether a new emergency permit is justified. Regeneron is conducting its own Covid prevention study in households where one member is infected.
Skovronsky said he also hopes the results will encourage people developing Covid to get antibody treatment. The use of the monoclonal antibodies was more sporadic than expected, partly due to distribution problems and partly because doctors and patients did not know about it. The government bought large supplies of antibodies from Lilly and Regeneron; whether the drugs are used more after governments have bought them makes no difference to the businesses.