A single infusion of an experimental drug markedly reduced levels of the coronavirus in newly infected patients and lowered the chances that they would need hospitalization, the drug’s maker announced on Wednesday.
The drug is a monoclonal antibody, a manufactured copy of an antibody produced by a patient who recovered from Covid-19, the illness caused by the coronavirus. Many scientists hope that monoclonal antibodies will prove to be powerful treatments for Covid-19, but they are difficult and expensive to manufacture, and progress has been slow.
The announcement, by Eli Lilly, was not accompanied by detailed data; independent scientists have not yet reviewed the results, nor have they been published in a peer-reviewed journal. The findings are the interim results of an ongoing trial.
More than 450 newly diagnosed patients received the monoclonal antibody or a placebo infusion. Some 1.7 percent of those who got the drug were hospitalized, compared with 6 percent of those who received a placebo — a 72 percent reduction in risk, Eli Lilly reported.
Levels of the coronavirus plummeted among participants who received the drug, and their symptoms were fewer, compared with those who got the placebo.
The treatments so far shown to help coronavirus patients — the antiviral drug remdesivir and the steroid dexamethasone — are intended only for hospitalized patients. Those with mild to moderate disease have had to wait and hope for the best.
Dr. Myron Cohen, director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill, said he was impressed. The clinical trial appears to be rigorous, and the results are “really compelling.”
Other companies, too, are developing monoclonal antibodies to combat the coronavirus, he noted: “This is the opening of a door.”
Dr. Rajesh T. Gandhi, an infectious disease specialist at Massachusetts General Hospital, applauded Eli Lilly for studying people with mild to moderate disease. “That’s where more than 80 percent of patients are,” he said.
Dr. Gandhi said it was encouraging that the drug seemed to have lowered amounts of the virus in the respiratory tract, and said it might mean that patients could be made less infectious. But that would be difficult to demonstrate, requiring enormous trials, he added.
While the data so far are “tantalizing,” Dr. Gandhi said, he wanted more detail and anticipated the completion of the study, which will include more patients.
Monoclonal antibodies are used to treat diseases from cancer to arthritis to eczema. But they are expensive and extremely difficult to manufacture.
To make its monoclonal antibody, researchers at Eli Lilly gathered blood plasma from people who had survived infections with the coronavirus, retrieving and testing thousands of antibodies from the plasma to find the ones that seemed most powerful.
Next the scientists determined that antibody’s genetic sequence and inserted DNA with that sequence into E. coli bacteria, turning them into tiny antibody factories. The bacteria were grown in huge stainless steel vats under aseptic conditions in a sterile room; the bacterial soup must be constantly monitored to ensure that it has not been contaminated by other microbes.
Once the vat is teeming with bacteria and brimming with antibodies, workers remove the soup and concentrate the antibodies for use as a drug. They ship the new drug to a plant for packaging and labeling, all the while maintaining aseptic conditions and keeping the antibodies chilled.
The process takes two to four weeks. The high cost of the monoclonal antibody results from the conditions that must be maintained to make such large quantities safely, Dr. Adams said.
The study will eventually enroll 800 patients of all ages and in all risk categories at sites across the United States. So far the research has proceeded with unusual speed.
Working feverishly, researchers at Eli Lilly needed just six months from isolating…
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