The only induction of the experimental drug has significantly reduced blood levels of coronavirus in newly infected patients and made them less likely to be hospitalized, the drug maker announced Wednesday.
The drug is a monoclonal antibody, a replica of a patient-produced antibody recovered from Covid-19, a disease caused by coronavirus. Many scientists hope that monoclonal antibodies will prove to be a powerful treatment for Covid-19, but they are difficult and expensive to manufacture, and progress has been slow.
Eli Lilly’s announcement, however, was not accompanied by detailed data; The results have not yet been reviewed by independent scientists, nor have they been published in a peer-reviewed journal.
These findings are the result of an interim trial sponsored by a pharmaceutical company. More than 450 newly diagnosed patients received monoclonal antibody or placebo infusion. About 1.7 percent of those who received the drug were hospitalized, compared to 6 percent of those who received a placebo – a 72 percent reduction in risk.
Blood levels of coronavirus were submerged in participants who received the drug, and their symptoms were lower than those who received placebo.
Every treatment shown so far to help coronavirus patients – antiviral drug rimadesivir and steroid dexamethasone – is intended only for critically ill hospitalized patients. People with mild to moderate disease have to wait and hope for the best.
The director of the Institute for Global Health and Infectious Diseases at Chapel Hill University of North Carolina, Dr. Myron Cohen said he was impressed.
“It’s exciting,” said Dr. Cohen, who was not involved in the study. Clinical trials seem tough, and the results are “really amazing.”
Other companies are also developing monoclonal antibodies to coronavirus, he noted: “This is a door opener.”
The study will eventually enroll 800 patients of all ages and all risk categories at sites in the United States. So far research has progressed at an unusual pace.
At six months, Ally Lilly isolated one of the first Covid-19 survivors, turned it into a drug, and began the study, which registered the first patients on June 17. ”Said. The company’s chief scientific officer is Daniel Schwronsky.
The goal was to register patients as soon as they became infected, but this meant speeding up the general selection process. Trial sites performed rapid diagnostic tests and moved quickly for registration of eligible patients.
Ally Lily also tests the drug in nursing homes to see if it prevents infection in residents and staff members.
In addition to constantly measuring the amount of coronavirus in the blood, investigators also sought to understand whether the pathogen is mutable to avoid antibodies.
They found that the virus was mutating, to some extent: 8% of those who received a placebo were infected with the virus, compared with 8% of those who took the drug. (Presumably, the virus was trying to dodge the natural antibodies that placebo patients make on their own.)
Investigators expect their drug to reduce the amount of virus in patients’ blood. They did not expect a sharp decline in patients who needed hospitalization.
“This is the first time we’ve ever seen anything of this intensity,” Dr. Sk said. Said Schvronsky.
He said the antibody drug does not produce significant side effects. Patients received the same stimulus, provided antibodies that lasted about a month.
These findings are good news regarding vaccination. If monoclonal antibodies had not worked, the discovery could have cast doubt on the notion that the virus could be stopped by antibodies.
The results, on the other hand, do not guarantee that a vaccine will work if it proves to be accurate. Ally Lily’s monoclonal antibody is a temporary treatment; A vaccine is designed to eliminate long-lasting natural antibodies and therefore immunity.
Like other companies, Ally Lilly manufactures its drug – in large quantities of 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. With the possibility of obtaining emergency consumption approval to allow Eli Lilly to sell the drug in the market, Scovronsky said.
Monoclonal antibodies are expensive to make and carry high cost TSGs, often thousands of dollars per dose. D if. “If the findings remain the same, people will be comforted to know that doctors can do something to alleviate the dreaded disease,” Cohen said.
He added, “My wife and I, who are old and fat – we are waiting for such drugs so that we can see our grandchildren.”
