[ad_1]
(Reuters) – Patients apply 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 Inc
Medical experts said more data is needed to assess the efficacy of the treatment before allowing wider use.
Trump was released from the hospital late Monday, just days after he was diagnosed with COVID-19 that caused enough lung inflammation for blood oxygen levels to drop.
According to his doctor, blood tests Monday detected infection-fighting antibodies, which a Regeneron spokesman said were likely from the treatment.
The company said Wednesday it submitted an application to the US Food and Drug Administration for an emergency use authorization (US) for its antibody combination.
In a video filmed outside the White House, Trump credited Regeneron therapy with feeling much better than when he was first diagnosed and said he would push for US of that treatment and others like it. He wrongly 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 the immune system generates to fight infection.
So far, the company has released some preliminary data pointing to the promise of its therapy for COVID-19, and doctors were concerned about Trump’s treatment and his subsequent promotion could put pressure on regulators.
Dr. Gary Kleiner, a pediatric 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 patients seeking the drug have reached out to him since last week.
Dr. Dirk Sostman, head of the Houston Methodist Hospital Research Network, a test site for Regeneron and Eli Lilly & Co
He was wary of the wider use without more data.
“All we’ve seen are very short press releases … so there’s not much to talk about,” he said.
“The politics of the situation would suggest to me that the story could be that Trump gets COVID … then American technology fostered by the Trump Administration cures COVID,” Sostman added. “I think there would be pressure on regulators.”
America’s leading infectious disease expert, Dr. Anthony Fauci, speaking on CNN on Monday, said he had “strong suspicions” that Regeneron’s drug contributed to Trump’s progress. “Obviously you can’t prove that until several studies are done to show that it really works,” he said.
Doctors emphasized that the timeline for Trump’s illness was not entirely clear. “If it’s responding at a rate where it really is much better, it will be because of the antibodies,” said Dr. Edward Jones-Lopez, an infectious disease specialist at the Keck School of Medicine at the University of Southern California in Los Angeles. Angels .
Giving the president treatment appears “a tacit endorsement of the federal medical bureaucracy for Regeneron medicine, and we expect a USA for COVID treatment in a matter of days,” Leerink analyst Geoffrey Porges said in a research note.
“The patients most likely to benefit from this treatment have a profile similar to that of President Trump, in that they had undetectable antibodies at the start of the study and were early in the course of the disease,” said a spokeswoman for Regeneron. , Alexandra Bowie, in an emailed statement.
Regeneron has received $ 450 million from the US government for up to 300,000 doses of the double antibody cocktail, and the company has said those supplies will be distributed free of charge.
Eli Lilly said Wednesday that a mid-stage trial testing his antibody combination therapy showed that it helped reduce hospitalizations and emergency room visits for COVID-19 patients and that he also planned to search for an EUA. Shares of Regeneron, which are up nearly 6% so far this month, closed at $ 591.69 on Wednesday. Lilly shares rose 3.4% on Wednesday to close at $ 148.96.
(Reporting by Deena Beasley; Editing by Peter Henderson, Bill Berkrot and Christopher Cushing)
[ad_2]
