Gilead to Kick Off Its Own Studies of Potential Coronavirus Drug--Update
February 26 2020 - 6:22PM
Dow Jones News
By Joseph Walker
Gilead Sciences Inc. said Wednesday it would start late-stage
studies of its experimental treatment for the coronavirus in March,
an acceleration of its push to evaluate what it hopes could be the
first medicine specifically approved to treat the respiratory
disease.
Gilead said it would conduct two studies with a total of 1,000
patients across mainly Asian countries, as well as other nations
with high numbers of diagnosed patients.
Gilead is kicking off the studies following the U.S. Food and
Drug Administration's acceptance of its investigational new-drug
application, an early first step for studying unproven drugs in
humans.
The studies, if successful, would help contribute to a larger
dataset needed to win regulatory approval for the drug. It is too
early to say if the two studies alone would be sufficient for
regulators, said Diana Brainard, Gilead senior vice president for
HIV and emerging viral infections.
"Things are moving so quickly, it's hard for us to gauge what
the right approval package would look like in the U.S. or abroad,"
Dr. Brainard said in an interview. "We're in data-collection mode
right now."
Gilead hopes to have at least an initial set of data results in
May, Dr. Brainard said.
Gilead's drug, remdesivir, is already being studied in two sets
of clinical trials. Chinese researchers earlier in February began
enrolling patients with both moderate and severe symptoms of
coronavirus.
On Tuesday, the National Institutes of Health announced the
start of the first U.S. study of remdesivir, which is being led by
researchers at the University of Nebraska.
In both the Chinese and NIH studies, patients are randomly
assigned to receive either remdesivir or a placebo; neither
patients nor researchers are informed who is receiving the actual
drug. The Gilead study, by contrast, won't include the placebo
option.
The first of the two Gilead studies will enroll 400 patients
with severe symptoms, with half of the subjects receiving
remdesivir infusions for five days, and half receiving 10 days of
infusions. Patients will be evaluated on whether their fevers
normalize and the amount of oxygen in their blood increases.
The second study will enroll 600 patients with moderate
symptoms. A third of the subjects will receive five days of
remdesivir treatment, a third will receive 10 days of remdesivir
and a third will receive only standard treatment and no remdesivir.
The study will evaluate the drug's effectiveness by the percentage
of patients discharged from the hospital within 14 days of
treatment.
Write to Joseph Walker at joseph.walker@wsj.com
(END) Dow Jones Newswires
February 26, 2020 18:07 ET (23:07 GMT)
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