NIH Halts Study Exploring Treating Covid-19 With Lilly Antibody, Remdesivir
October 26 2020 - 8:41PM
Dow Jones News
By Peter Loftus
Federal health researchers have halted testing a combination of
Eli Lilly & Co.'s Covid-19 antibody drug and remdesivir in
hospitalized Covid-19 patients, after an independent committee
found a lack of a benefit.
The National Institute of Allergy and Infectious Diseases, which
is funding the study, said Monday it was planning to test other
experimental drugs as Covid-19 treatments in the study. Lilly said
it would continue testing its antibody drug in other studies.
The decision may not affect the U.S. Food and Drug
Administration's appraisal of Lilly's antibody drug, which is up
for authorization as a solitary treatment for patients with mild to
moderate Covid-19 and not hospitalized.
Enrollment in the study of the drug combination had been paused
earlier this month due to a potential safety concern.
An independent board overseeing the trial found a difference in
the clinical status between Covid-19 patients who received the
Lilly drug and those who got a placebo.
NIAID had said it ordered the pause out of an abundance of
caution, and Lilly said it supported the move to ensure patient
safety.
After reviewing updated data from the study, however, the
independent board on Monday found no significant differences in
safety outcomes between patients getting the Lilly drug and those
on placebo.
Instead, the board's decision to recommend that no further
patients be given the Lilly drug in the study "was driven by lack
of clinical benefit" in hospitalized patients, NIAID said.
Some 326 patients had been enrolled in the study, and
researchers will continue to follow them for 90 days.
Lilly's drug, code named LY-CoV555, is essentially a clone of
immune-system agents known as antibodies that fight infections.
Lilly is codeveloping the drug with AbCellera Biologics Inc., of
Vancouver, Canada, which isolated antibodies from a blood sample
taken from one of the earliest Americans to recover from
Covid-19.
The trial testing whether adding LY-CoV555 to Gilead Sciences
Inc.'s remdesivir would benefit people hospitalized with Covid-19
began in August. Remdesivir is approved to treat serious
hospitalized Covid-19 patients.
The trial's close is a setback in efforts to find better
treatments for Covid-19, but Lilly said the drug continues to have
potential to help people at earlier stages of Covd-19 than
hospitalized patients.
Lilly said Monday all other studies of LY-CoV555 are still
ongoing, including in nonhospitalized patients and residents and
staff at long-term care facilities.
The Indianapolis-based company also said that while there was
insufficient evidence that its drug improved clinical outcomes in
hospitalized patients, it was confident that the drug may prevent
progression of disease for those earlier in the course of
Covid-19.
A separate study testing the drug alone found that it reduced
hospitalizations in patients with mild to moderate forms of the
disease.
Based on that study, Lilly asked the FDA earlier this month to
authorize emergency use of the antibody in nonhospitalized people
with recently diagnosed mild-to-moderate Covid-19.
Write to Peter Loftus at peter.loftus@wsj.com
(END) Dow Jones Newswires
October 26, 2020 20:26 ET (00:26 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
Eli Lilly (NYSE:LLY)
Historical Stock Chart
From Aug 2024 to Sep 2024
Eli Lilly (NYSE:LLY)
Historical Stock Chart
From Sep 2023 to Sep 2024