Eli Lilly says other COVID-19 antibody drug trials ongoing after study halted for safety concern

By Carl O’Donnell and Michael Erman



a large building: FILE PHOTO: Eli Lilly logo is shown on one of their offices in San Diego


© Reuters/MIKE BLAKE
FILE PHOTO: Eli Lilly logo is shown on one of their offices in San Diego

(Reuters) – Eli Lilly & Co on Wednesday said other trials of its experimental coronavirus antibody therapy remain on track after a government-run study testing the treatment in hospitalized COVID-19 patients was paused due to safety concerns.

Lilly said on Tuesday that an independent safety monitoring board requested a pause in the trial, called ACTIV-3, due to a potential safety issue.

The National Institutes of Health (NIH), which is collaborating with Lilly on the trial, said the advisory board paused the trial after seeing a “difference in clinical status” between patients on Lilly’s drug on those who received a placebo, without providing further detail.

Lilly on Wednesday said the paused trial is distinct from others it is conducting because it focuses on hospitalized patients who are more severely ill and being treated with other drugs as well, including Gilead Sciences Inc’s antiviral remdesivir.

The company had already asked U.S. regulators for an emergency use authorization (EUA) for the antibody drug, called bamlanivimab or LY-CoV555, to treat mild to moderate COVID-19 patients, based on interim data from a different study in those less severe illness. It is also testing the drug in nursing homes to see if it can prevent staff and residents from getting infected.

The U.S. Food and Drug Administration did not immediately respond to a request for comment on the status of the EUA application.

LY-CoV555 is similar to the experimental dual-antibody therapy from Regeneron Pharmaceuticals Inc that was used to treat U.S. President Donald Trump. That treatment is also awaiting clearance by U.S. regulators.

Trump touted both drugs as being tantamount to cures in a video he posted last week after being released from the hospital.

Lilly said in a statement that these type of treatments may prove to be less beneficial for hospitalized patients than for those with more mild cases of the disease. A Lilly spokeswoman declined to comment further on why the trial was halted.

The paused trial is being conducted in partnership with the U.S. National Institute of Allergy and Infectious Diseases, a division of the NIH that is working with several drugmakers on COVID-19 treatments and vaccines.

It was halted at the request of an independent oversight panel, called a Data Safety and Monitoring Board (DSMB). It is not uncommon to pause drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem.

“Lilly trusts the judgment of the independent DSMB and supports its decisions to exercise caution in ensuring the safety of the patients participating in this study,” the company said in a statement.

(Reporting by Carl O’Donnell; Editing by Chizu Nomiyama and Bill Berkrot)

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Eli Lilly pauses trial of antibody drug Trump touted as COVID-19 ‘cure’ over safety concern

By Michael Erman and Carl O’Donnell

(Reuters) – Eli Lilly and Co said on Tuesday that the government-sponsored clinical trial of its COVID-19 antibody treatment similar to one taken by U.S. President Donald Trump has been paused because of a safety concern.

Trump touted the Lilly drug, along with the antibody treatment from Regeneron Pharmaceuticals Inc that he received for his COVID-19, as tantamount to a cure in a video he posted last week.

The announcement comes one day after Johnson & Johnson said it was forced to pause a large high-profile trial of its experimental coronavirus vaccine because a volunteer fell ill. J&J said it does not yet know if that person was given the vaccine or a placebo.

AstraZeneca Plc’s U.S. trial for its experimental COVID-19 vaccine has also been on hold for over a month after a volunteer in its UK study fell ill. Trials of that vaccine resumed in other regions after a brief halt.

Lilly said earlier this month it was applying for emergency use authorization (EUA) for the antibody drug, LY-CoV555, for patients with mild to moderate COVID-19 based on data from another clinical trial.

It is not uncommon to pause drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem. Because of the urgent need for drugs and vaccines to tackle a pandemic that has claimed over 1 million lives worldwide – and the speed with which they are being developed – these trials have come under intense scrutiny.

“Out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” Lilly spokeswoman Molly McCully said in an emailed statement. “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

The Indianapolis-based drugmaker did not comment on the implications for the paused trial, called ACTIV-3, which is testing the treatment on COVID-19 patients who require hospitalization, or on its other ongoing trials. It is also testing the drug in nursing homes to see if it can prevent staff and residents from getting infected.

The U.S. Food and Drug Administration and the National Institutes of Health did not immediately reply to requests for comment.

Lilly began its ACTIV-3 trial in August and is aiming to recruit 10,000 patients primarily in the United States.

The trial compares patients who receive its antibody drug plus Gilead Sciences Inc’s antiviral drug remdesivir with those who receive remdesivir alone.

Lilly sought the EUA from U.S. regulators after publishing data in September showing LY-CoV555 helped cut hospitalization and emergency room visits for COVID-19 patients. The treatment is being developed with Canadian biotech AbCellera.

Lilly shares closed nearly 3%.

(Reporting by Michael Erman and Carl O’Donnell in New York; Additional reporting by Deena Beasley in Los Angeles; Editing by Bill Berkrot)

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Eli Lilly antibody trial paused over safety concerns

Checking in: The trial design calls for the data and safety monitoring board to examine results from the first 300 participants — including their need for supplemental oxygen, mechanical ventilation or other supportive care five days after receiving the treatment or a placebo — before proceeding with further enrollment.

The NIAID trial has so far enrolled 326 patients. An agency spokesperson said that the board overseeing the trial this morning “reached a predefined boundary for safety at day five.” The board will now decide whether the trial should add 700 more participants.

The NIAID spokesperson added that the pause in enrollment is “out of an abundance of caution” and the safety board is “continuing data collection and follow-up of current participants for safety and efficacy.”

The late-stage study is examining whether Lilly’s antibody, known as bamlanivimab, could help hospitalized patients. The treatment is a monoclonal antibody that mimics the antibodies the body makes naturally. It’s similar to the Regeneron antibody cocktail that President Donald Trump received recently after being diagnosed with Covid-19.

Background: Last week, Lilly asked the FDA to grant an emergency-use authorization that would allow use of the antibody treatment in high-risk patients recently diagnosed with mild-to-moderate Covid-19.

That application is largely based on preliminary data from a Phase II trial released in mid-September that showed patients who received any dose of the antibody were less likely to be hospitalized or visit the ER.

What’s next: The data and safety monitoring board overseeing the trial will review data again at a preplanned meeting on October 26. The board will recommend at that meeting whether or not enrollment should be resumed, according to NIAID.

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