Regeneron (REGN) - Get Report and Sanofi (SNY) - Get Report said they'd treated the first patient outside the U.S. in a trial, within a global clinical program, of a drug designed to treat patients hospitalized with severe Covid-19.
The companies are evaluating Kevzara, generically sarilumab, in a multicenter double-blind Phase II/III trial with patients in Italy, Spain, Germany, France, Canada, Russia and the U.S.
"Data from a single-arm study in China suggest that the interleukin-6 pathway may play an important role in the overactive inflammatory response in the lungs of patients with Covid-19," George D. Yancopoulos, a physician who is chief scientific officer of Regeneron, said in a statement.
"Despite this encouraging finding, it's imperative to conduct a properly designed, randomized trial to understand the true impact of Kevzara, which we are now doing through this global clinical trial program."
Kevzara is described as a "fully human monoclonal antibody" that reduces the overactive inflammatory response in the lungs of patients who have contracted Covid-19.
That overactive response is what makes the disease fatal as the body's immune system overreacts to the virus.
"These trials will provide important data to determine whether Kevzara ameliorates the life-threatening complications of Covid-19 infections by counteracting the overactive inflammatory immune responses in the lungs when damaged by the virus," said John Reed, a physician who is Sanofi's global head of research and development.
Kevzara's trial will target patients who are critically ill from the disease. This trial follows up a 21-patient trial the two companies conducted in China. There, 15 of 21 patients saw reduced fevers and reduced need for supplemental oxygen.
The companies said that Regeneron, Tarrytown, N.Y., is leading the U.S. trials while Sanofi, Paris, is leading them outside the U.S.
At last check Regeneron shares were higher by 2.7% at $461.47. Sanofi rose 1.8% to $43.19.