A single infusion of an experimental drug has significantly reduced coronavirus blood levels in newly infected patients and reduced the chances of them needing hospitalization, the drug manufacturer announced on Wednesday.
The drug is a monoclonal antibody, a produced copy of an antibody produced by a patient who recovered from Covid-19, the disease caused by coronavirus. Many researchers hope that monoclonal antibodies will prove to be effective treatments for Covid-19, but they are difficult and expensive to manufacture, and progress has been slow.
The announcement of Eli Lilly did not accompany detailed data; independent researchers have not yet reviewed the results, nor have they been published in a peer-reviewed journal.
Blood levels in coronavirus decreased among participants who received the drug and their symptoms were fewer compared to those who received placebo.
Every treatment that has so far been shown to help coronavirus patients – the antiviral drug remdesivir and steroid dexamethasone – is only intended for seriously ill patients. Those with mild to moderate illness 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.
“It’s exciting,” said Dr. Cohen, who was not involved in the investigation. The clinical trial appears to be rigorous, and the results are “truly compelling.”
Other companies are also developing monoclonal antibodies to fight coronavirus, he noted: “This is the opening of a door.”
The study will eventually enroll 800 patients of all ages and in all risk categories in places in the United States. So far, the research has progressed exceptionally fast.
At six months, Eli Lilly isolated an antibody from one of the first Covid-19 survivors, turned it into a drug, and started a study in which the first patients were enrolled on June 17th. “It was a total effort,” said Dr. Daniel Skovronsky, the company’s scientific director.
The goal was to enroll patients as soon as they were infected, but that meant speeding up the usual selection process. Experimental sites administered rapid diagnostic tests and moved rapidly to enroll qualified patients.
Eli Lilly also tests the drug in nursing homes to see if it prevents infections in residents and staff.
In addition to constantly measuring the amount of coronavirus in blood, investigators also tried to understand whether the pathogen mutated to avoid antibodies.
They found that the virus was changing to some degree: 8 percent of the viruses had mutated in participants who received the drug, compared with 6 percent in those who received placebo. (Presumably, the virus also tried to dodge the natural antibodies that placebo patients made on their own.)
The investigators expected that their drug might lead to a reduction in the amount of virus in the patients’ blood. They did not expect a sharp reduction in patients in need of hospitalization.
“This is the first time we’ve ever seen anything of this size,” said Dr. Skovronsky.
The antibody drug did not produce significant side effects, he said. Patients were given a single infusion that delivered antibodies that were to last about a month.
There is good news about a vaccine in these findings. If monoclonal antibodies had not worked, the finding may have raised doubts about the notion that the virus can be stopped with antibodies.
On the other hand, the results – if proven accurate – do not guarantee that a vaccine will work. Eli Lilly’s monoclonal antibody is a temporary treatment; a vaccine is designed to elicit long-lasting natural antibodies and thus immunity.
Like other companies, Eli Lilly has manufactured large quantities of its drug – 100,000 doses – in the hope that it will prove effective.
The company will discuss its data with the Food and Drug Administration, said Dr. Skovronsky along with the possibility of obtaining an emergency use authorization that allows Eli Lilly to market the drug.
Monoclonal antibodies are expensive to manufacture and carry high price tags, often thousands of dollars per. Dosage. But if the results hold up, there will be comfort to the public by knowing that there is something doctors can do to stave off serious illness, said Dr. Cohen.
“For my wife and I, who are older and fatter – we are waiting for drugs like this so we can see our grandchildren,” he added.