Experimental drug may reach patients in weeksAn experimental treatment for the new coronavirus is expected to begin clinical testing on Korean patients within the next several weeks.
The Foster City, California-based Gilead Sciences announced Thursday it will start a global clinical trial program next month to test the efficacy and safety of remdesivir, an experimental medicine developed for Ebola, in treating novel coronavirus patients. The company became widely known after developing and marketing a highly effective treatment for hepatitis C.
The drug has not yet won regulatory approval for the treatment of any disease. But an apparent success story in the United States has raised hopes among global health authorities that it could be an effective treatment to combat the epidemic sweeping across Korea and much of the world.
The New England Journal of Medicine reported that the United States’ first coronavirus patient started recovering just one day after receiving remdesivir. According to the article, all symptoms had vanished within days, except for a cough, which was also improving as time went on.
“The speed with which remdesivir has moved into clinical development for this coronavirus reflects the pressing need for treatment options and the shared commitment of industry, governments, global health organizations and health care providers to respond to this public health threat with the highest urgency,” Gilead Sciences Chief Medical Officer Merdad Parsey said in a statement.
The upcoming study, consisting of two Phase 3 clinical trials, is recruiting a total of 1,000 patients across the world in a bid to prove the clinical improvement potential of remdesivir.
For the first stage, Gilead will administer the drug to 400 patients with severe cases of Covid-19, the name that the World Health Organization has assigned to the virus. The cohort will be randomly divided to receive either five or 10 days of the treatment. The second stage will gather 600 patients with moderate cases of the coronavirus to divide them randomly to receive five days or 10 days of remdesivir or standard care alone.
Gilead said the program is primarily focused on testing the experimental Ebola drug on patients at medical centers in Asian countries, as well as others with a high number of diagnosed cases.
The company hopes to release the results for the two clinical studies as early as May.
Remdesivir is already in the midst of three ongoing clinical trials in Wuhan, Beijing and Omaha, for which Gilead has donated the needed drug volume. The company expects to hear results from the two ongoing Chinese studies by April.
While the latest studies are geared toward coronavirus patients in a number of affected countries, it is likely many of them will be in Korea, as the country has reported the second-highest number of confirmed cases so far.
Korean health authorities have reported more than 1,500 confirmed cases of Covid-19, with more than a dozen deaths.
Gilead said it has not yet determined how many patients from each country will be included in the studies.
The company said Thursday it filed applications with the Ministry of Food and Drug Safety and the U.S. Food and Drug Administration to start the program.
The Ministry of Food and Drug Safety said Wednesday that it will prioritize clinical trial requests for remdesivir ahead of anything else to ensure the drug is given to patients in Korea as soon as possible.
Currently all volume of remdesivir is manufactured through contract manufacturing organization partnerships in the United States and Europe. Gilead has secured some volume of the experimental drug for tests as an Ebola treatment, and some of that volume has been recently used for test treatments of the novel coronavirus cases.
To offset growing demand for remdesivir as the coronavirus epidemic continues to grow, Gilead said it may also establish an internal manufacturing system for the two clinical studies and official sales if the drug wins approval from regulators.
Even if the drug doesn’t win final approval for sale in Korea, the 1,000-patient program could provide needed help to patients in Korea who have been demanding new and better treatments.
Some local patients have been treated with an H.I.V. drug, Kaletra, and a malaria treatment, hydroxychloroquine. The Ministry of Food and Drug Safety is also discussing a regulatory exemption for the import of Avigan, a drug made by Tokyo’s Toyama Chemical and approved for treatment of influenza in 2014.
BY KO JUN-TAE [firstname.lastname@example.org]