2020.09.16 07:38
A single infusion of an experimental drug has markedly reduced blood levels of the coronavirus in newly infected patients and lowered the chances that they will need hospitalization, the drug’s maker announced on Wednesday.
The drug is a monoclonal antibody, a man-made 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 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 a trial sponsored by Eli Lilly and the National Institutes of Health. Officials at the N.I.H. declined to comment until they have more thoroughly reviewed the data.
According to Eli Lilly, 452 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.
Blood levels of the coronavirus plummeted among participants who received the drug, and their symptoms were fewer, compared with those who got the placebo.
Every treatment so far shown 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 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.
“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 compelling.”
Other companies, too, are developing monoclonal antibody drugs to combat the coronavirus, he noted: “This is the opening of a door.”
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Eli Lilly Reports Success With COVID-19 Neutralizing Antibody Treatment
An experimental COVID-19 treatment hit the mark in an 800-patient clinical trial.
Cory Renauer
(TMFang4apples)
Sep 16, 2020 at 2:11PM
Author Bio
Get ready for the best coronavirus news we've seen from the biopharmaceutical industry to date. An interim peek at a clinical trial with an experimental treatment from Eli Lilly (NYSE:LLY) suggests LY-CoV555 could be an effective treatment option for COVID-19 patients with mild-to-moderate symptoms.
The first experimental COVID-19 antiviral treatment to score
The FDA has granted, and in some cases rescinded, emergency use authorizations for COVID-19 treatments that were around before SARS-CoV-2 made its debut in late 2019. If authorized, Lilly could launch the first treatment aimed directly at the novel coronavirus responsible for the pandemic. Back in March, Eli Lilly and its collaboration partner, AbCellera, isolated a pair of promising antibodies, LY-CoV555 and LY-CoV016, from a panel of more than 500 proteins found in blood samples of COVID-19 patients who recovered.
IMAGE SOURCE: GETTY IMAGES.
In June, Eli Lilly and AbCellera began the Blaze-1 study, a controlled, randomized trial currently testing LY-CoV555, and a combination of LY-CoV555 and LY-CoV016 as potential treatments for patients with mild-to-moderate COVID-19 symptoms. The primary outcome being measured is the difference in viral load 11 days after beginning treatment, and it looks like one of three dosages of LY-CoV555 tested as a monotherapy hit the mark.
At the interim analysis, the 2,800-milligram dosage significantly reduced the amount of circulating SARS-COV-2, but the differences observed with the 700-milligram dosage and the 7,000-milligram dosage didn't reach statistical significance on day 11.
It's important to hit the goals set out at the beginning of a clinical trial, but outcome measurements are what matters most. An ongoing phase 3 trial with LY-CoV555 will provide a clearer picture, but it looks like this treatment will become a powerful weapon for healthcare providers fighting the COVID-19 pandemic. COVID-19-positive patients treated with any dosage strength were 77% less likely to report a COVID-19-relatedhospitalization or ER visit.