- Gilead on Wednesday launched two late-stage studies of its experimental antiviral remdesivir as a potential treatment for the new coronavirus, throwing its own clinical development muscle into a now global effort to test whether the drug is effective in easing infection symptoms.
- Two trials of remdesivir, which was originally developed to treat Ebola virus infections, are already underway in China, led by researchers at the China-Japan Friendship Hospital. Another study, sponsored by the U.S. National Institutes of Health, began enrolling patients in Nebraska this week.
- "This complementary array of studies helps to give us a more expansive breadth of data globally on the drug’s profile in a short amount of time," said Merdad Parsey, Gilead's chief science officer, in a Feb. 26 statement. No data yet show whether remdesivir is effective against SARS-CoV-2, as the new coronavirus is now known, but animal testing data demonstrated it's active against the SARS and MERS viruses.
Clinical study of remdesivir has accelerated rapidly as health authorities and the biotech respond to the fast-spreading coronavirus epidemic, which has now spread to 37 countries.
For the China studies and the NIH trial, Gilead has donated supplies of remdesivir and lent its expertise. The clinical tests announced Wednesday will be run by the biotech itself, primarily in Asian countries but also in nations with high numbers of diagnosed cases.
Patient enrollment will begin in March, Gilead said, and will test two dosing regimens of remdesivir through two weeks post treatment. The biotech anticipates enrolling 1,000 patients into the two studies — slightly more than trials ongoing in China.
Results from those two are expected in April, and the NIH study could yield data quickly, too.
"We will know reasonably soon whether it works," said Anthony Fauci, head of the infectious disease division of the National Institutes of Health, at a Feb. 26 press conference.
Up until this month, little attention was being paid to remdesivir, which had proved ineffective in preventing deaths from Ebola in a study run in the Democratic Republic of the Congo.
But the spread of SARS-CoV-2 in China and beyond brought the compound back into the spotlight, as preclinical testing had given some signs it might be effective against SARS and MERS, two other coronaviruses.
A case report published last month in the New England Journal of Medicine suggested treatment with remdesivir might have played a role in the recovery of the first U.S. patient infected with SARS-CoV-2, although researchers weren't certain.
A recent NIH study in monkeys, meanwhile, showed remdesivir successfully prevented disease from infection by the MERS virus.
Gilead had stockpiled some supplies of remdesivir for potential use in checking Ebola's spread in Africa. The company is now drawing down those supplies to provision the two studies in China and to respond to compassionate use requests.
Preparing for the possibility remdesivir does prove effective against SARS-CoV-2, Gilead says it is now working to widen its network of manufacturing partners, and to internally manufacture the drug as well.
If remdesivir doesn't benefit patients, the pipeline of other promising drugs ready for study is thin, consisting mainly of existing HIV or influenza antivirals.
More than a dozen drugmakers are now developing potential vaccine and therapeutic candidates, although only a few of those efforts are being conducted by companies large enough to run wide-scale clinical testing or to manufacture large quantities of experimental drug.