Eli Lilly and Co says interim results from its study of an antibody drug shows it may prevent mild to moderately ill coronavirus patients from being hospitalized.
The antibody, LY-CoV555, was developed by Indianapolis-based Lilly and the Canadian company AbCellera.
It recognizes the virus once a person is infected and attaches to it, preventing the pathogen from spreading throughout the body.
Hospitalization or ER visits were about three times less likely in COVID-19 patients given the drug than those given a placebo.
The company announced the results on Wednesday in a press release, but they have not been published or reviewed by independent scientists.
Hospitalization or ER visits occurred in 1.7% of 302 mild to moderately ill coronavirus patients given Eli Lilly’s antibody drug and 6% of those given the placebo. Pictured: Eli Lilly & Co corporate headquarters in Indianapolis, January 2010
The drug did not reduce the amount of virus patients had after 11 days, except the middle of three doses being tested. Pictured: Members of the medical staff prepare to transfer a patient to another room in the COVID-19 intensive care unit at the United Memorial Medical Center in Houston, Texas, July 2020
‘I’m strongly encouraged’ by the results, said Dr Myron Cohen, a virologist at the University of North Carolina School of Medicine.
He had no role in the Lilly study but helps direct antibody studies for a public-private research group the federal government formed to speed testing of these drugs.
‘This seems to demonstrate what we thought’ – that such drugs would give a benefit, he said.
A total of 450 people with COVID-19 symptoms not severe enough to warrant hospitalization were recruited for the mid-stage study.
The drug is given once through an IV and was tested at three doses. Neither the patients nor their doctors knew which patients received the drug or placebo infusions.
Hospitalization or ER visits occurred in 1.7 percent of 302 patients given the drug and six percent of those given the placebo, a 72 percent risk reduction.
No serious side effects or deaths were reported among patients.
The drug missed the study’s main goal of reducing the amount of virus patients had after 11 days, except the middle of three doses being tested at 2,800 milligrams.
However, most study participants, even those given a placebo treatment, had cleared the virus by then, so that time point now seems too late to judge that potential benefit, the company said.
The company felt that giving the actual numbers ‘told the story in the most balanced way,’ said Dr Daniel Skovronsky, Lilly’s chief scientific officer.
‘The results reinforce our conviction that neutralizing antibodies can help in the fight against COVID-19.’
The company said most hospitalizations occurred in patients who were among higher-risk groups, such as being elderly or underlying risk factors such as being elderly or obese, suggesting a more pronounced treatment effect for people in these higher-risk groups.
Lilly said it would talk with regulators about possible next steps but that it was too soon to speculate on whether these interim results might lead to any action to allow early use.
Antibodies are proteins the body makes when an infection occurs. They attach to a virus and help it be eliminated.
The blood of survivors – convalescent plasma – is being tested as a treatment for COVID-19 patients because it contains such antibodies.
However, the strength and types of antibodies varies depending on each donor, and doing this on a large scale is impractical.
The drugs that Lilly and other companies are testing are concentrated versions of specific antibodies that worked best against the coronavirus in lab and animal tests, and can be made in large, standardized doses.
They are being tested to treat newly diagnosed COVID-19 patients in hope of preventing serious disease or death, and to try to prevent infection in people at high risk of these outcomes such as nursing home residents and health workers.
The difference seems large enough to suggest a true benefit and the result is ‘promising’ even though the study missed its main goal, said Dr Peter Bach, a health policy expert at Memorial Sloan Kettering Cancer Center in New York who was not involved in the study.
The trial, which has now enrolled 800 patients with mild-to-moderate COVID-19, is being test in combination with another Lilly antibody, LY-CoV016, which binds a different park of the spike protein the virus uses to enter human cells.
Lilly has already started manufacturing its antibody drug, hoping to have hundreds of thousands of doses ready by fall if studies give positive results.
Another company that developed an antibody drug cocktail against Ebola – Regeneron Pharmaceuticals Inc – now is testing a two-antibody drug for coronavirus.
Link nguồn : https://www.dailymail.co.uk/health/article-8739369/Study-hints-antibody-drug-cut-COVID-19-hospitalizations.html
