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’s Antibody Trial Is Paused Over Potential Safety Concern

A government-sponsored clinical trial that is testing an antibody treatment for Covid-19 developed by the drugmaker Eli Lilly has been paused because of a “potential safety concern,” according to emails that government officials sent on Tuesday to researchers at testing sites. The company confirmed the pause.

The news comes just a day after Johnson & Johnson announced the pause of its coronavirus vaccine trial because of a sick volunteer, and a month after AstraZeneca’s vaccine trial was halted over concerns about two participants who had fallen ill after getting the company’s vaccine.

The Eli Lilly trial was designed to test the benefits of the antibody therapy on hundreds of people hospitalized with Covid-19, compared with a placebo. All of the study participants also received another experimental drug, remdesivir, which has become commonly used to treat coronavirus patients. It is unclear exactly what safety issues prompted the pause.

In large clinical trials, pauses are not unusual, and declines in health in volunteers are not necessarily the result of the experimental drug or vaccine. Such halts are meant to allow an independent board of scientific experts to review the data and determine whether the event may have been related to the treatment or occurred by chance.

“This is why clinical trials are essential,” said Marion Pepper, an immunologist at the University of Washington. “The safety of the product has to be empirically proven.”

Enrollment for the Eli Lilly trial, which was sponsored by several branches of the National Institutes of Health and the Department of Veterans Affairs, among other organizations, had been continuing. But on Tuesday, multiple officials sent emails to researchers telling them to stop adding volunteers to the study out of an “abundance of caution.”

In a statement, an N.I.H. spokeswoman said the trial, which had enrolled 326 Covid-19 patients, was paused when the independent safety board found that after five days of treatment, the group of patients who had received the antibodies showed a different “clinical status” than the group who had received a saline placebo — a difference that crossed a predetermined threshold for safety.

The N.I.H. statement did not specify the nature of the participants’ conditions. But the so-called stopping rules for the trial lay out the conditions for “futility” — the idea that a treatment has a very low chance of working, based on the data so far. A trial could also be halted if there is evidence that patients in one group are faring much worse than those in the other.

Given the ambiguity in the statements released on Tuesday, all scenarios remain possible, said Dr. Eric Topol, a clinical trials expert at the Scripps Research Institute. “It’s so amorphous,” Dr. Topol said.

The safety board will review the data again on Oct. 26, and advise the N.I.H. on whether to resume the trial, the statement said. In the meantime, researchers will continue to collect data from people already enrolled in the study.

Several experts praised the trial’s sponsors for halting the trial to address

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