What happens when the N-of-1 is the president of the US? Regeneron is about to find out
President Trump is taking a very personal interest in another experimental drug for Covid-19.
Friday afternoon, after he had tested positive for coronavirus, the White House put out a statement saying that Trump had taken an 8 gram dose of Regeneron’s antibody cocktail — the high dose that appeared to do better than the low dose in terms of batting down viral loads.
Right after word arrived that Trump had taken the experimental therapy, he was transferred to Walter Reed — news that immediately heightened fears about his condition. The Washington Post noted that Trump and his team decided to make the move while he could still walk.
The president’s physicians didn’t stop with the cocktail. Late Friday night, the president’s spokesperson stated that the doctors started a course of remdesivir, the Gilead drug that won the first emergency use authorization from the FDA on modestly positive trial results.
New statement from WH Physician Sean Conley MD reports Pres Trump “doing very well” tonight at Walter Reed.. “He is not requiring any supplemental oxygen,” and is receiving Remdesivir therapy, a drug the Pres himself has often trumpeted. Says he “is resting comfortably.” pic.twitter.com/SR1IIwmXrH
— Mark Knoller (@markknoller) October 3, 2020
Earlier in the week Regeneron — led by CEO Len Schleifer and chief scientist George Yancopoulos — had stirred a mixed reaction to its first cut of the data on their cocktail, essentially providing proof-of-concept data for the drug without solid evidence of efficacy in easing the path of the patients with initially mild cases of Covid-19.
While Regeneron offered data demonstrating that the drug could reduce the need for medical visits among patients with a low immune response, the numbers involved were far too low to offer any clear picture regulators normally need for an OK. The use of the drug may indicate that Trump is among the most vulnerable group.
Trump, though, has a history of touting drugs based on little to no evidence they work. He took hydroxy long after the data pointed to its ineffectiveness. And he pushed the FDA to provide an emergency OK for convalescent plasma on thin evidence that it could work to fight the virus.
Trump’s response to the Regeneron cocktail, real or simply self-diagnosed, could have enormous consequences for the biotech — though adding remdesivir could make it near impossible to tease out a response now. The star antibody drug maker is seeking an emergency OK and may soon have the president in their corner if he pulls through quickly.
Any serious setbacks from here, though, could threaten to turn Trump into an influential opponent.
So far right now, the president is a very big N of 1. And the initial market response is all positive. Regeneron’s stock surged 5% after hours Friday — not bad when you start with a market cap of $60 billion.
Trump himself offered a late-night thumbs up:
Going welI, I think! Thank you to all. LOVE!!!
— Donald J. Trump (@realDonaldTrump) October 3, 2020
Biopharma companies don’t typically like getting compassionate use requests for their drugs, seeing little upside when they work and a big downside when they don’t. But as Schleifer told Katie Thomas at the New York Times: “When it’s the president of the United States, of course, that gets — obviously — gets our attention.”
Also of note: Trump had a choice in experimental antibodies. Eli Lilly touted its approach before Regeneron arrived on the scene, and their therapy — which disappointed a number of analysts on the first snapshot of data — didn’t make the cut. That can’t sit well at the pharma giant.
In addition to the cocktail, Trump also is taking zinc, vitamin D, famotidine, melatonin and a daily aspirin.
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