US plans trial of Gilead coronavirus drug remdesivir

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The U.S. is planning a clinical trial of Gilead’s experimental drug for the novel coronavirus, according to a posting on a government clinical trials database.

The trial, run by the University of Nebraska Medical Center along with the National Institute of Allergy and Infectious Diseases, will be conducted at up to 50 sites globally, and will test the medicine, called remdesivir, against placebo, according to the protocol. At the time of the post on Friday, the trial was not yet recruiting patients.

A World Health Organization doctor, Bruce Aylward, said Monday after a tour through China that Gilead’s medicine is the only one that appears to have promise against COVID-19, the disease caused by the novel coronavirus. It’s being tested in two trials in Wuhan, China, the epicenter of the outbreak, though Aylward noted slow enrollment in those studies because of declining patient numbers and trials of other medicines also being conducted.

“We have got to start prioritizing enrollment into those things that may save lives and save them faster,” Aylward said at a press briefing Monday in China. “And that’s a global issue, not China, it’s a global issue.”

Gilead’s shares rose 4.6% Monday but were down more than 1% in early trading Tuesday. The stock, which has a market value of about $92 billion, has gained nearly 11% over the past year.

Gilead referred a request for comment to the NIAID, which didn’t immediately respond. A spokesman for the University of Nebraska Medical Center said he was unable to comment until information is publicly released.

Gilead is among a dozen companies in the race to develop treatments, vaccines and diagnostic tests for the novel coronavirus. Monday, biotech company Moderna said it had shipped the first batch of its potential vaccine to the NIAID to start human trials, sending its stock up 16 percent Tuesday.

Remdesivir is an experimental antiviral drug that has shown some promise against other coronaviruses that cause SARS and MERS, but it hasn’t been tested in humans with coronaviruses. It was tested in people with Ebola — which is caused by a different kind of virus — and was unsuccessful.

The medicine was also used to treat the first U.S. patient with the novel coronavirus, according to a case study published last month in the New England Journal of Medicine. The patient appeared to improve the next day, but researchers note one patient’s experience is not enough to determine whether the medicine works.

By Meg Tirrell
CNBC

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