A single infusion of an investigational drug significantly reduced blood levels of the coronavirus in newly infected patients and reduced the chances they would need hospitalization, the drug’s manufacturer announced Wednesday.
The drug is a monoclonal antibody, a manufactured copy of an antibody made by a patient recovered from Covid-19, the disease caused by the coronavirus. Many scientists hope that monoclonal antibodies prove to be potent treatments for Covid-19, but they are difficult and expensive to produce, 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.
Coronavirus blood levels plummeted among participants who received the drug, and their symptoms were lower than those who received placebo.
Every treatment so far proven to help coronavirus patients – the antiviral drug remdesivir and the steroid dexamethasone – is intended only for seriously ill hospitalized patients. Those with mild to moderate illnesses 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 study. The clinical trial appears to be rigorous and the results are “really convincing”.
Other companies are also developing monoclonal antibodies to fight the coronavirus, he noted: “This is opening a door.”
The study will eventually enroll 800 patients of all ages and in all risk categories at sites in the United States. So far the research has progressed with unusual speed.
In six months, Eli Lilly isolated an antibody from one of the earliest Covid-19 survivors, turned it into a drug, and started a study, enrolling the first patients on June 17. “It was a total effort,” said Dr. Daniel Skovronsky, scientific director of the company.
The goal was to enroll patients as soon as they were infected, but this meant speeding up the normal selection process. Test sites delivered rapid diagnostic tests and quickly moved on to enrolling suitable patients.
Eli Lilly is also testing the drug in nursing homes to see if it prevents infections in residents and staff members.
In addition to constantly measuring the amount of coronavirus in the blood, the researchers also tried to figure out if the pathogen was mutating to avoid antibodies.
They found that the virus was changing, to some extent: 8% of the viruses had mutated in the participants receiving the drug, compared with 6% in those receiving the placebo. (Presumably, the virus was also trying to dodge the natural antibodies that the placebo patients were producing on their own.)
The researchers expected their drug to produce a reduction in the amount of the virus in patients’ blood. They did not anticipate a large reduction in patients requiring hospitalization.
“This is the first time we’ve seen something of this magnitude,” said Dr. Skovronsky.
The antibody drug produced no significant side effects, he said. Patients received a single infusion, providing antibodies which should last approximately one month.
There is good news regarding a vaccine in these findings. If the monoclonal antibodies didn’t work, the discovery may have cast doubt on the idea 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 produced large quantities of his drug – 100,000 doses – in hopes that it will prove effective.
The company will discuss its data with the Food and Drug Administration, Dr. Skovronsky said, along with the possibility of obtaining an emergency use permit that would allow Eli Lilly to market the drug.
Monoclonal antibodies are expensive to manufacture and carry high price tags, often thousands of dollars per dose. But if the results hold up, there will be solace for the public in knowing that there is something doctors can do to ward off a serious illness, Dr Cohen said.
“For my wife and I, who are bigger and fatter, we are waiting for drugs like this so we can see our grandchildren,” he added.