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Gilead prepares for Chinese trials of antiviral after treating U.S. patient

As Gilead plans Chinese trials of remdesivir to treat the coronavirus, health authorities in Washington state reported that compassionate use of the nucleotide analog prodrug resolved almost all disease symptoms in one infected patient. The antiviral will join at least nine other trials under way in China for therapies to treat 2019-nCoV.

Sonia Choi, a spokesperson for Gilead Sciences Inc. (NASDAQ:GILD), told BioCentury the company expects to begin enrolling patients mid-February in two trials evaluating remdesivir to treat 2019-nCoV acute respiratory disease.

Patients will receive 10 days of IV remdesivir. The primary endpoint of both studies will be clinical improvement at 28 days.

Study details, including patient numbers, will be posted in the near future by the principle investigator for the trials, Choi said.

According to ClinicalTrials.gov and the Chinese Clinical Trial Registry, there are at least nine trials listed for 2019-nCoV treatments, and one for an assay (see “Clinical Trials for Coronavirus”).

In the three weeks since the first 2019-nCoV sequence was posted to a public database on Jan. 9, multiple biopharma companies and academic labs have launched vaccine development programs (see “The Race is On”).

Case study

Gilead has also provided remdesivir for emergency use in a small number of patients with 2019-nCoV.

Data for the compassionate use of remdesivir to treat the patient in Washington were published Jan. 31 in The New England Journal of Medicine.

The patient was admitted on Jan. 20 to Providence Regional Medical Center in Everett after nasopharyngeal and oropharyngeal swabs tested positive for 2019-nCoV. His symptoms included fever, cough, fatigue, vomiting and diarrhea. On the evening of the patient’s seventh day of hospitalization, he was given an infusion of remdesivir. The next day, the patient’s appetite and oxygen saturation improved. By Jan. 30, all of his symptoms had resolved except his cough, though it had decreased in severity.

The antiviral therapy was originally developed in response to the Ebola virus outbreak and is the result of a partnership with CDC and the U.S. Army Medical Research Institute for Infectious Diseases that explored whether molecules originally explored as potential treatments for other viruses, including HCV, RSV and the flu, might be active against emerging viruses.

Remdesivir is thought to block a key enzyme needed for viral replication.

A 2017 study in mice showed that an injection of remdesivir before or after severe acute respiratory syndrome coronavirus (SARS-CoV) infection decreased weight loss and viral load in the lung and increased lung function (see “Distillery”).

Preliminary data from a Phase III Ebola trial showed remdesivir had a mortality rate of 53% compared with 67% for no treatment.

Gilead gained $3.16 to $66.36 Monday, adding about $4 billion in market cap.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus. The 2019-nCoV content is free to all who visit the site.

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