Regeneron could release data within weeks about how well its arthritis drug Kevzara is battling the new coronavirus, its chief scientific officer said during a STAT video chat Wednesday.
George Yancopoulos, who is also the Tarrytown, N.Y.-based biotech’s co-founder, made it clear during the chat that the battle, for him, is personal.
“I can’t believe the devastation we’re facing here in New York, at the epicenter, and the bad news is so many people have already died and are in hospitals, and are on ventilators,” said Yancopoulos,, who grew up in Queens. He used that word, “devastation,” again and again, mentioning “friends on ventilators” who have been afflicted with Covid-19, the disease caused by the coronavirus, and those at risk.
“I tragically right now have a 91-year-old aunt who’s trapped in a nursing home where right now there’s a coronavirus outbreak,” he said. “And I just wish I could get them our [drug] today. It’s just not ready.”
Yancopoulos also issued an impassioned plea on behalf of the pharmaceutical industry. “The vast majority are well-meaning people who devote their lives to use science to make a difference and address disease,” he said, adding that society must understand the need to prepare scientifically for “true existential threats” such as future pandemics and climate change. The only thing that makes human beings different from bacteria trapped in an Erlenmeyer flask, Yancopoulos, said, is that we can work together to think our way out of problems.
For all the recent focus on discussing drug pricing, the bigger enemy is disease, he said. “Let’s show humanity can rise.”
That’s typical bluster and passion from one of the drug industry’s most dynamic figures. Yancopoulos, then a young assistant professor at Columbia University, was recruited by Leonard Schleifer, Regeneron’s chief executive, shortly after the company was founded in 1988. The company spent years developing the technology behind its antibody drugs, becoming a big success in 2011 with the approval of the eye drug Eylea, which now accounts for 60% of the company’s $7.9 billion in annual sales.
Regeneron threw itself into the battle against SARS-CoV-2, the novel coronavirus, and Covid-19, the disease it causes, with typical energy, testing an existing arthritis drug it sells with partner Sanofi, Kevzara, in hospitalized patients and also working to develop new antibody drugs that might treat or prevent infection.
Twenty-one patients treated in China with a similar, rival drug, Roche’s Actemra, saw some benefit, according to a report. Yancopoulos, gave credit to local and national government officials for pushing Regeneron and Sanofi to start their trial, calling New York Gov. Andrew Cuomo “prescient” and talking about a midnight, weekend phone call with Stephen Hahn, the commissioner of the Food and Drug Administration, and Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
The FDA encouraged Regeneron to embrace a study design that would test the drug in a two-step process without stopping. The first part of the study, due to end soon, will look to see if there is any benefit and to figure out how to measure it. Then, the ongoing study could be used to double check that the effect is actually there, based on the measures that appear potent in the first study phase. That first stage is what could finish soon.
“We are probably a couple weeks or a month away from getting a controlled data answer to really understand whether this shot really makes a difference in a controlled way in patients,” Yancopoulos said. “And I think we all need to know, because we’re all so desperate. We want these things to work.”
Regeneron’s other effort is to create antibody drugs against the coronavirus. Yancopoulos, emphasized that the endgame against the virus would be to create a vaccine. But vaccines work by training the body to create its own antibodies against a virus. Synthetic antibodies might be available sooner. Regeneron is producing these using genetically engineered mice that have human-like immune systems, and by looking at the blood of patients who have recovered. Yancopoulos reiterated that the company is aiming to start human studies in June, with hope that the antibodies might be available by the fall for some uses.
These antibodies will be tested as a way to prevent infection, to prevent infection from worsening, and to treat very ill hospitalized patients.
Other companies are neck-and-neck with Regeneron in similar efforts. Vir Biotechnology has said that it plans to start human studies of its drug this summer, as have Eli Lilly and its partner AbCellera. And even more antibody efforts are behind those.
One viewer asked Yancopoulos why studies of these new medicines must include an arm that randomly assigns some patients to get an inert placebo, not the potential medicine.
Yancopoulos recounted an example from early in Regeneron’s history. One of its first experimental treatments was for Lou Gehrig’s disease, or amyotrophic lateral sclerosis. There was a “60 Minutes” report asking how Regeneron could expose some patients to placebo given reports of how much patients were improving on the drug. But when the study finished, patients had done as well on the placebo group. The study had failed.
“Right now, unfortunately, nothing exists that’s better than doing a rigorous, controlled study,” Yancopoulos said. “The FDA holds you to that. And I know from looking at how many times we and other people have been fooled over the decades, the world needs it to really know whether these things are working.”
Did you read the entire article? Pay more attention to these two points:
The FDA encouraged Regeneron to erace the study design?
Spoke with the two most important people at the FDA for drug approval (Stephen Hahn and Janet Woodcock)?
Do you know what does it mean?
For those who think that coming up with drugs is fast and easy, even for Regeneron, note that the company took 20 YEARS to get their first drug approved after it was founded in 1988. Anything accomplished in months is close to being miraculous. Anyone wanting to start a biotech company today should be aware that investors now would not put a dime into a company if management told them it thought it would take 20 years for launch of their first drug.
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