Gilead climbs as coronavirus drug shows efficacy, starts trial
Gilead has made progress in its effort to reposition failed Ebola drug remdesivir as a treatment for the coronavirus sweeping across China. In quick succession, it emerged that the nucleotide analogue prodrug appeared to help the first U.S. case of the virus and is set to undergo clinical testing in China, sending Gilead’s stock up by as much as 13% in premarket trading.
Remdesivir was one of a clutch of drugs tested against Ebola, but it failed to match the efficacy of its rivals, leading its development against that virus to come to a halt. However, preclinical tests have suggested the drug is effective against murine hepatitis virus and Middle East respiratory syndrome coronavirus, leading Gilead to propose it as an answer to the outbreak that began in Wuhan, China.
Gilead publicly floated the idea of using remdesivir to treat the coronavirus, dubbed 2019-nCoV, 10 days ago. Since then, the effort to advance the drug in the indication has gathered pace.
A paper published in The New England Journal of Medicine (NEJM) late last week described the use of the drug on the first 2019-nCoV patient in the U.S. Ten days into the illness, the patient was showing signs of pneumonia, required supplemental oxygen, suffered ongoing fevers and was positive for 2019-nCoV RNA at multiple sites.
On day 11, the physicians administered remdesivir on a compassionate use basis. The next day, the patient’s condition improved, leading to the discontinuation of supplemental oxygen and cessation of all symptoms apart from intermittent dry cough and rhinorrhea.
As the authors of the NEJM paper state, randomized controlled trials are needed to validate the signs of efficacy seen in the compassionate use case. A hospital in Wuhan plans to run such a clinical trial. Bloomberg, following up on an article in the Chinese media, reports China-Japan Friendship Hospital plans to randomize 270 patients with mild-to-moderate pneumonia related to 2019-nCoV to receive remdesivir or placebo.
If, as happened in the compassionate use case, participants in the trial improve after receiving the antiviral, Gilead could position remdesivir as a front-line treatment for 2019-nCoV. AbbVie has similar aspirations for its HIV drug Kaletra.
Feb 3, 2020