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Regeneron suspends antibody treatment trials for severe Covid patients



Regeneron has stopped recruiting severely ill Covid-19 patients in clinical trials of antibody therapy, and US President Donald Trump called this therapy a “cure” of the disease.

After an independent data monitoring committee warned that for hospitalized patients with high oxygen levels, the risks could outweigh the benefits, Regeneron’s stock price fell 3%.

The move came after Eli Lilly, which is also developing Covid-19 antibody therapy, stopped trials in hospitalized patients earlier this week, when the team found that the group was unlikely to benefit.

Both companies have submitted emergency use permit applications to the US Food and Drug Administration to treat mild to moderate Covid-1

9 patients (including Mr. Trump who fell ill earlier this month).

Dan Lucey, an infectious disease expert at Georgetown University, said that regulators should convene an external advisory board before issuing an emergency use authorization, which has never been approved for monoclonal antibodies.

He said: “The FDA needs to carefully examine the evidence on safety and whether the treatment is really effective to avoid repeated errors because it has issued emergency use permits for hydroxychloroquine and restorative plasma” to treat Covid-19.

The Regeneron trial will continue to be conducted in outpatients and inpatients with hypoxia or anaerobicity, which shows that the focus on safety is limited to the most sick participants. However, because the drug is administered by drip, it may be difficult to dispense to mild patients who are not in the hospital.

Eric Topol, director of the Scripps Research and Translational Institute, said that biologically speaking, this kind of treatment can attack the virus earlier, but it does not treat the body’s overexpression of the disease. Active immune response.

He said: “The window is small, the sooner the better.” He added that any safety issues for severely ill patients will not cause concerns for patients with mild to moderate Covid-19.

Due to potential safety concerns, clinical trials of Eli Lilly’s antibodies were initially suspended in early October. But when the company announced on Monday to abandon the trial unit, it said the safety differences between the groups were not significant.

The US government has signed a supply contract for two therapies to enhance the human immune system through artificially produced antibodies. Regeneron has reached a $450 million deal to produce and supply its antibody blend, and Eli Lilly announced earlier this week that it reached a preliminary agreement for $375 million.

Trump was treated with Regeneron when he contracted this disease. In the video in early October, he praised the drug and said it made him feel good immediately, and suggested that the drug would be approved. Regeneron CEO Leonard Schleifer occasionally plays golf with the president.

Antibody therapy may become an important tool for physicians. Despite the investment in drug trials, there are still not many drugs that can treat Covid-19, and there are concerns about Gilead’s remdesivir as the only antiviral drug approved by US regulators and how effective it is.

Geoffrey Porges, an analyst at SVB Leerink, said he is “very confident” that the antibody therapy will receive emergency approval. He said that there is still a market for about 40% to 50% of inpatients.

In New York midday trading on Friday, Regeneron shares fell 2.6% to $541.31. Eli Lilly (Eli Lilly) shares fell 1.6% to 130.44 US dollars.

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