More patients seek to join trials for drug taken by US leader

The company so far has released some early data pointing to the promise of its therapy for Covid-19. PHOTO: NYTIMES

WASHINGTON • Patients are asking to join clinical trials of antibody-based Covid-19 drugs after US President Donald Trump was treated last week with an experimental therapy from Regeneron Pharmaceuticals, and promised on Wednesday to make it free to Americans while touting its benefits.

Mr Trump also declared that catching the coronavirus was a "blessing from God" that exposed him to experimental treatments.

Medical experts said more data is needed to assess the Regeneron therapy's efficacy before wider use should be allowed.

Mr Trump was discharged from hospital late on Monday, after announcing early last Friday that he and his wife both had been diagnosed with Covid-19.

According to his doctor, blood tests on Monday detected infection-fighting antibodies, which a Regeneron spokesman said were probably from the treatment.

The company said on Wednesday that it has submitted a request to the United States Food and Drug Administration for an emergency use authorisation (EUA) for its antibody combination.

In a video shot outside the White House, Mr Trump credited the Regeneron therapy for his feeling much better than when he was first diagnosed, and said he would push for EUAs of that treatment and others like it.

He mistakenly said the drug was called Regeneron.

Regeneron's drug is a cocktail of two monoclonal antibodies - manufactured copies of antibodies that are one of the main weapons that the immune system generates to fight infections.

The company so far has released some early data pointing to the promise of its therapy for Covid-19, and doctors were concerned Mr Trump's treatment and subsequent promotion could put pressure on regulators.

Dr Gary Kleiner, a paediatric immunologist at the University of Miami Miller School of Medicine and an investigator in a trial designed to see if Regeneron's antibodies can prevent coronavirus infection, said he has been approached by patients seeking the drug since last week.

Dr Dirk Sostman, head of the research network at Houston Methodist Hospital, a trial site for Regeneron and Eli Lilly antibody programmes, said more patients are asking to participate in an antibody trial.

He was cautious about allowing broader use without more data.

"All we have seen are very brief press releases... so there is not much to go on," he said.

"The politics of the situation would suggest to me that the story could be Trump gets Covid... then American technology fostered by the Trump administration cures Covid," Dr Sostman added.

"I would think there would be pressure on regulators."

Top US infectious disease expert Anthony Fauci, speaking on Monday on CNN, said he was "strongly suspicious" that Regeneron's drug has contributed to Mr Trump's progress.

"Obviously you can't prove that until you do a number of studies to show that it actually works," said Dr Fauci.

Mr Trump, in a video address released on Wednesday, said: "I think this was a blessing from God that I caught it. This was a blessing in disguise."

He added that his use of the medication from Regeneron had allowed him to experience first-hand how effective it could be.

"I want to get for you what I got. And I'm going to make it free," he said, at one point calling the unapproved medicine a "cure".

Mr Trump, who faces Democrat Joe Biden in the Nov 3 election, has had no Covid-19 symptoms for the past 24 hours, said his doctor Sean Conley in a statement.

"He's now been fever-free for more than four days, symptom-free for over 24 hours, and has not needed, nor received, any supplemental oxygen since initial hospitalisation," Dr Conley said.

REUTERS

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A version of this article appeared in the print edition of The Straits Times on October 09, 2020, with the headline More patients seek to join trials for drug taken by US leader. Subscribe