Agence France-PresseSeptember 17, 2020 10:06:34 AM
A drug company says partial results of a study testing an antibody drug suggest it may help prevent mild to moderate COVID-1
Eli Lilly announced the results in a press release on Wednesday, but they have not been published or verified by independent scientists.
The drug missed the study’s main goal of reducing the number of virus patients after 11 days, except in the middle of three doses tested. Most study participants, even those who received placebo treatment, had cleared the virus by then, so the time now seems too late to assess these potential benefits, the company said.
Other tests suggest the drug reduced the virus earlier, and the results are encouraging “proof of the principle” as these and other studies continue, Lilly said.
The company said it will speak to regulators about possible next steps, but it is too early to speculate on whether these interim results could lead to measures to allow early application.
“I am greatly encouraged” by the results, said Dr. Myron Cohen, a University of North Carolina virologist. He didn’t have a role in the Lilly study, but is helping with direct antibody studies for a public-private research group the federal government set up to expedite the testing of these drugs.
“This seems to show what we thought” – that such drugs would be of benefit, he said.
Antibodies are proteins that the body produces when infected. They attach themselves to a virus and help get rid of it. Survivors’ blood is tested to treat COVID-19 patients because it contains such antibodies. However, the strength and type of antibodies will vary from donor to donor and it is impractical to do so on a large scale.
The drugs Lilly and other companies are testing are concentrated versions of specific antibodies that work best against the coronavirus in laboratory and animal studies and can be made in large, standardized doses.
They are being tested to treat newly diagnosed COVID-19 patients in hopes of preventing serious illness or death, and to try to prevent infection in those at high risk such as nursing home residents and health workers.
Wednesday’s results come from 450 people who tested an antibody in an interim study jointly developed by Lilly of Indianapolis and Canadian company AbCellera in people with COVID-19 symptoms who are not severe enough to be hospitalized justify. The drug is administered once through an IV and has been tested in three doses. Neither the patients nor their doctors knew which patients were receiving the drug or placebo infusions.
1.7% or 5 out of 302 patients given the drug and 6% or 9 out of 150 patients given placebo were hospitalized or emergency rooms. The company did not disclose whether these results corresponded to scientific tests to rule out that they could have been caused by chance alone.
The company believed that giving the actual numbers “tells the story in the most balanced way,” said Lilly’s chief scientist, Dr. Daniel Skovronsky.
The difference seems big enough to indicate a real benefit and the result is “promising,” although the study missed its main objective, said Dr. Peter Bach, a health policy expert at the Memorial Sloan Kettering Cancer Center in New York, who does not play a role in the study.
The study will continue to test the antibody drug in combination with another Chinese company, Junshi Biosciences. Three late-stage studies are also ongoing, including two that were sponsored by the US National Institutes of Health.
Lilly has already started making its antibody drug and hopes to have hundreds of thousands of doses ready by fall if studies show positive results.
Another company that has developed a cocktail of antibodies against Ebola – Regeneron Pharmaceuticals Inc. – is currently testing a drug with two antibodies for coronavirus.