Regeneron Pharmaceuticals Inc. has found itself in the spotlight after President Donald Trump was treated with the company’s experimental antibody treatment for Covid-19, just days after the unveiling of promising preliminary trial results.
The Tarrytown, New York-based biotechnology company said it had provided a single high dose of the drug for Trump after receiving a compassionate-use request from his doctors. Trump is at higher risk of severe Covid-19 complications due to his age and clinical obesity.
Monoclonal antibodies are considered one of the most promising potential treatments for Covid-19, and Regeneron is one of the front-runners in testing them. They have the potential to be used both as a treatment and as a quick-acting prophylactic medication in people who are likely to have been exposed to the virus.
Anthony Fauci, the top U.S. infectious-disease official, has referred to the medicines as a bridge to a vaccine.
Trump may be an ideal person to benefit from the experimental therapy, which is an artificial version of the antibodies the immune system naturally makes to fight off infection. Since Trump was diagnosed so quickly, the treatment could help jump-start his fight against the pathogen.
Regeneron’s cocktail therapy is a mix of two highly potent antibodies against the coronavirus spike protein. It is being tested in several clinical trials in both hospitalized Covid-19 patients and patients outside the hospital.
The preliminary results from one trial released this week showed the drug may help treat coronavirus patients outside of the hospital by reducing virus levels and symptoms. In a trial of 275 Covid-19 patients, those who got Regeneron’s experimental therapy had lower virus levels in the bloodstream seven days later compared with patients who received a placebo.
On a conference call after the results were released, Regeneron executives said they would discuss with U.S. regulators whether the new data was sufficient to move forward with an application for an emergency-use authorization.
Sign of Worry
It’s likely that the president’s symptoms are worse than the White House is acknowledging, given the use of Regeneron’s experimental therapy, said Walid Gellad, director of the Center for Pharmaceutical Policy & Prescribing at the University of Pittsburgh. While there is more than just the president’s personal health at stake, since he is the leader of the U.S., it wouldn’t make sense to use a still-unproven therapy for a virus that the majority of people recover from without complications.
“The fact that he received this is an indication of how worried people are about his condition,” Gellad said in an interview.
“There are risks to experimental therapy, and presumably it’s given because in his particular case the risks outweigh benefits,” Gellad said on Twitter. “If it was really mild cold symptoms they would not give him experimental therapy. At least I highly doubt it.”
In a statement, Regeneron said it had provided the drug for compassionate use “under rare, exceptional circumstances.”
Trump’s use of the experimental drug could affect the progress of the company’s clinical-trial work, as well as raise issues of fairness and access given Regeneron is still trying to develop the medication and produce enough to determine whether it’s safe and effective, Gellad said.
Regeneron is one of several pharmaceutical companies pursuing experimental antibody therapies, including AstraZeneca Plc, GlaxoSmithKline Plc and its partner Vir Biotechnology Inc., and Eli Lilly & Co.
Lilly’s monoclonal antibody is also far along in testing and is seen a competitor to Regeneron’s cocktail. The Indianapolis-based drugmaker said on Sept. 16 that its treatment reduced the rate at which symptomatic patients were hospitalized compared to a placebo, according to preliminary study results.
A spokesperson for Lilly declined to comment on the president’s treatment.
— With assistance by Riley Griffin
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October 03, 2020 at 05:04AM
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Trump Treatment Thrusts Regeneron Virus Drug to Center Stage - Bloomberg
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