Gilead to Kick Off Its Own Studies of Potential Coronavirus Drug--Update

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 [e-mail]

(END) Dow Jones Newswires

February 26, 2020 18:07 ET (23:07 GMT)

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