Regeneron stopped enrolling a seriously ill Covid-19 patient in a clinical trial of an antibody therapy that US President Donald Trump hailed as the “cure” for the disease.
Regeneron shares fell as much as 3% after an independent data monitoring committee warned that the risks could outweigh the benefits for hospitalized patients with high oxygen levels.
The move comes after Eli Lilly, which is also developing a Covid-19 antibody treatment, stopped testing in hospitalized patients earlier this week, when it found that the group did not have any. ability to benefit.
Both companies have applied for an emergency use license to the US Food and Drug Administration to treat patients with mild to moderate Covid-19 disease – a bag including Mr. Trump, who fell ill earlier this month.
Dan Lucey, an infectious disease expert at Georgetown University, said the regulator should convene a committee of outside advisers before issuing an emergency use license, which has never been granted for resistance. monoclonal form.
“The FDA needs to carefully examine the evidence for safety – and whether the treatments are really effective – to avoid the occurrence of mistakes they made when issuing,” he said. emergency use of hydroxychloroquine and nourishing plasma “for Covid-19 treatment.
Regeneron trials will continue in outpatients and hospitalized patients in either hypoxic or hypoxic conditions, suggesting any safety concerns are limited to the sickest participants. But since the drug is provided in a drip form, it may be difficult to distribute it to less ill patients who are not hospitalized.
Eric Topol, director of the Scripps Research Translation Institute, said that biologically, the treatment had a pre-existing effect on the virus, but did not treat the body’s overactive immune response. with this disease.
“There is a small window and as soon as possible,” he said, adding that any safety issues in patients with more severe illness should not raise concerns about Covid patients- 19 from mild to moderate.
Eli Lilly antibody testing in initial hospitalized patients was halted due to possible safety concerns as early as October. But when the company announced on Monday it would abandon the arm. In that test, they reported that the difference in the safety levels between the groups was negligible.
The US government has contracted to provide both treatments that boost the body’s immune system with artificially produced antibodies. Regeneron has a $ 450 million deal to produce and deliver its antibody cocktails, while Eli Lilly announced earlier this week an initial deal for $ 375 million.
Mr. Trump treated Regeneron while he was sick. In a video in early October, he praised the drug, saying it made him instantly comfortable, and hinting that it was about to be approved. Leonard Schleifer, Regeneron’s chief executive, has occasionally played golf with the president.
Antibody therapies can become an important tool for physicians. Despite investment in drug trials, there are few options for treating Covid-19 and there are concerns about how Gilead’s remdesivir works, the only antiviral drug that has been administered by the regulator. Approved by United States.
Geoffrey Porges, an analyst at SVB Leerink, said he is “very confident” that antibody therapies will receive urgent approval. He says it’s still possible to have a market for about 40 to 50 percent of hospitalized patients.
Shares of Regeneron fell 2.6% to $ 541.31 in Friday afternoon trading in New York, while Eli Lilly fell 1.6% to $ 130.44.
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