By Michael Erman and Axel Threlfall
(Reuters) – Initial data from clinical trials testing whether patients with severe coronavirus illness can be helped by a rheumatoid arthritis drug sold by Regeneron Pharmaceuticals Inc and Sanofi SA may come as early as next week, Regeneron’s chief scientific officer told Reuters.
“We could be one to two weeks – at most a month or so – away from knowing whether this is really making a difference or not,” George Yancopoulos said of the drug Kevzara in a video interview on Wednesday ahead of a Reuters Events pharmaceutical conference next week.
The U.S. biotech company is also working to develop a drug made from antibodies from humans and mice that could be used for treatment or prevention of COVID-19, the highly contagious respiratory disease caused by the novel coronavirus. That could be in clinical trials by June, said Yancopoulos, who co-founded Regeneron with Chief Executive Len Schleifer.
Kevzara belongs to a class of drugs known as interleukin-6 inhibitors that could help regulate an overreaction to the virus by the body’s immune system called a cytokine storm, which may be triggering the respiratory distress seen in severe COVID-19 cases.
Because of that, the drug is being tested on severe cases of the disease, which has killed some 90,000 people and wreaked havoc on economies around the world.
The U.S. Food and Drug Administration encouraged Regeneron and Sanofi to combine planned mid- and late-stage clinical trials of Kevzara into a single study to speed the process, Yancopoulos said.
The companies should know if they are a seeing a strong signal on whether the drug works after a few weeks of enrolling patients, he said. The U.S. Kevzara trial started on March 16.
If the drug proves effective, supply should not be an issue, Yancopoulos said, noting that as many as a million doses have already been produced with the capacity to manufacture a lot more.
“This is treating the small percentage of people who end up being hospitalized and going on ventilators and so forth,” he said. “So there would be reasonable amounts of drug available.”
BRIDGE TO VACCINE
Meanwhile, Regeneron recently isolated hundreds of virus-neutralizing antibodies from genetically-modified mice and from humans who have recovered from COVID-19 and is working to select the best two candidates for a therapy that might treat and even prevent the disease.
The company used a similar approach to develop a treatment for Ebola. That drug has not yet been fully evaluated by health regulators, but was shown in clinical trials to cut mortality nearly by half.
“It’s a bridge, ultimately, to the vaccine… something that we can do in the short term,” Yancopoulos said. “We can maybe do it actually more powerfully than a vaccine can do it, though for a smaller targeted population than a vaccine can reach.”
He said Regeneron is working with the FDA to repurpose its upstate New York manufacturing facility to become totally dedicated to producing drugs for the pandemic. It could make “hundreds of thousands, if not on the order of a million doses a month” of the antibody cocktail there.
Other companies have approached Regeneron about helping produce massive quantities of the antibody therapy should it prove effective in preventing COVID-19, Yancopoulos said.
“If these things work, let’s make sure we can put as much manufacturing capacity as we can on it right now,” he said.
(Reporting by Michael Erman; Editing by Bill Berkrot)