Eli Lilly pauses trial of antibody drug Trump touted as COVID-19 'cure'
over safety concern
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[October 14, 2020]
By Michael Erman and Carl O'Donnell
(Reuters) - Eli Lilly and Co <LLY.N> 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 <REGN.O> 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 <JNJ.N> 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 <AZN.L> 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."
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Eli Lilly logo is shown on one of the company's offices in San
Diego, California, U.S., September 17, 2020. REUTERS/Mike Blake
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 <GILD.O> 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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