Eli Lilly ends antibody trial early after failed to help in recovery
Eli Lilly ends paused trial of antibody drug and remdesivir after the NIH found the combo failed to help recovery of hospitalized patients
- Eli Lilly & Co and the National Institues of Health announced they are ending a clinical trial of antibody drug
- The study was looking at a combination of the antibody, LY-CoV555, and remdesivir as a treatment for hospitalized coronavirus patients
- Investigators paused the trial on October 13 due to ‘potential safety concerns’ and out of an ‘abundance of caution’
- NIH officials say they found no safety concerns but that there was no difference between patients receiving the drug and those getting a placebo
- Lilly says it will continue to test the drug in other studies and is waiting for FDA approval for the antibody as a solo treatment for mildly ill COVID-19 patients
Eli Lilly & Co has ended its clinical trial of an antibody drug early after it was shown to not help hospitalized coronavirus patients recover.
The ACTIV-3 study of the antibody LY-CoV555 (also known as bamlanivimab) was paused on October 13 due to ‘potential safety concerns’ and out of an ‘abundance of caution.’
However, company officials have not revealed what the safety concerns were, or how many hospitalized participants were affected, after a pause was recommended by an independent safety board.
In this particular trial, the antibody was being tested in combination with remdesivir, which recently became the first drug granted full US Food and Drug Administration (FDA) approval as a COVID-19 treatment.
In a statement on Monday, the National Institutes of Health (NIH), which was sponsoring the trial, said the antibody treatment did not have any safety risk.
However, investigators found that there was no significant difference in outcomes between patients getting Lilly’s drug and those receiving a placebo.
The National Institues of Health and Eli Lilly & Co announced they are ending clinical trial of a combination of an antibody, LY-CoV555, and remdesivir as a treatment for hospitalized coronavirus patients. Pictured: Eli Lilly corporate headquarters in Indianapolis, April 2017
Investigators paused the trial on October 13 due to ‘potential safety concerns’ and out of an ‘abundance of caution.’ Pictured: A researcher at Eli Lilly tests possible COVID-19 antibodies in a laboratory in Indianapolis, May 2020
NIH officials say they found no safety concerns but that there was no difference between patients receiving the drug and those getting a placebo, Pictured: Eli Lilly researchers prepare cells to produce possible COVID-19 antibodies for testing in a laboratory, May 2020
‘The [Data and Safety Monitoring Board] reviewed data from the ACTIV-3 trial…and recommended no further participants be randomized to receive LY-CoV555,’ the NIH statement read.
‘This recommendation was based on a low likelihood that the intervention would be of clinical value in this hospitalized patient population.’
Before the trial closed, 326 participants had been enrolled and they will continue to be followed for 90 days.
Lilly told The Wall Street Journal that it will continue testing its antibody therapy in other studies, and does not expect the recent news to impact its success.
Additionally, the drugmaker is waiting to see if the FDA grants approval for the drug as a solo treatment for mild to moderately ill COVID-19 patients who are not hospitalized.
Lilly did not immediately reply to DailyMail.com’s request for comment.
The antibody was developed by Indianapolis-based Lilly and the Canadian company AbCellera Biologics.
It recognizes the virus once a person is infected and attaches to the spike-shaped protein the virus uses to infect cells, preventing the pathogen from spreading throughout the body.
Antibodies are proteins that the body makes when it is infected. They attach to the virus to kill it.
The blood of COVID-19 survivors, known as convalescent plasma, is currently being tested as a treatment for patients because it contains these antibodies.
However, the types of antibodies a donor has, and their strength, can vary, which makes large-scale production unrealistic.
Lilly says its antibody treatment was developed after it was identified from a blood sample taken from one of the first US patients who recovered from COVID-19.
The drugs that Lilly and other companies are testing are concentrated versions of specific antibodies, which can be produced in mass 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.
In an earnings call on Tuesday, the drug maker said its net income fell to $1.208 billion, or $1.33 a share, in the third quarter, down from $1.254 billion, or $1.37 a share, during the same time last year.
According to Reuters, Lilly said it expects COVID-19 research and development this year to cost around $400 million, which led to shared dropping four percent before the opening bell.
Source: Read Full Article