Sanofi and Regeneron Pharmaceuticals have started a clinical trial to evaluate an experimental treatment in patients hospitalized with severe COVID-19, the companies said on Monday.
The companies initiated a global testing program for Kevzara, a fully-human monoclonal antibody that is already approved to treat adults with rheumatoid arthritis, in up to 400 patients.
The announcement came as global confirmed cases of COVID-19, the disease caused by the novel coronavirus, neared 175,000 and deaths topped 6,500. In the U.S., there are 3,813 reported cases and 69 deaths, according to a database run by Johns Hopkins University.
|REGENERON PHARMACEUTICALS INC.
There is no vaccine for the disease, and public health officials have repeatedly cautioned that once a vaccine is developed, it may not be applicable for a "year to a year and a half" due to delays from testing, development, production and distribution.
Regeneron, based in Tarrytown, New York, and Sanofi, a French company, will evaluate how the drug affects patients' fevers and need for supplemental oxygen. Regeneron will lead the U.S.-based trial and will immediately begin enrolling patients across 16 sites, beginning in New York, one of the hot spots in the U.S. outbreak.
Sanofi will lead trials outside of the U.S., including in countries hardest hit by the pandemic, such as Italy.
"Additionally, we expect to rapidly initiate trials outside the U.S. in the coming weeks, including areas most affected by the pandemic," said Dr. John Reed, Sanofi's global head of research and development.
In February, Regeneron announced a partnership with the U.S. Department of Health and Human Services to develop a coronavirus treatment.
Earlier this month, drug executives told the Trump administration that antivirals could be available for patients within a matter of months.
"I think what was exciting to hear around the table is you have a potential for a bridge. A bridge between the therapeutics and the monoclonals while we work on the vaccines. And I think that is the most promising piece for the American people," Debbie Birx, the White House's coronavirus response coordinator, said.