LLY Eli Lilly and Co

By Peter Loftus 

Eli Lilly & Co. said it has requested U.S. authorization for the emergency use of an experimental antibody-based treatment for people with recently diagnosed, mild-to-moderate Covid-19, a step that could open the door to a new class of coronavirus treatments capable of helping early cases and perhaps even preventing them.

Lilly said it is manufacturing doses of the drug, which was derived from a blood sample of one of the earliest U.S. survivors of Covid-19, and could have 100,000 doses this month and as many as one million by the end of the year.

If cleared for use, the drug could be the first to treat less severe cases of Covid-19. The few other therapies authorized for Covid-19 treatment, including remdesivir from Gilead Sciences Inc. and convalescent plasma, target hospitalized patients with more serious cases.

Lilly said it would seek authorization for use in higher-risk patients to prevent their recently diagnosed mild- to moderate disease from worsening to a severe state. Executives of the Indianapolis-based company said higher-risk groups may include people 65 years of age and older or obese patients.

"Anything that helps with preventing hospitalization and preventing progression is going to be a big advance," Rajesh Tim Gandhi, an infectious-disease physician at Massachusetts General Hospital and Harvard Medical School, said in an interview.

Lilly's antibody drug could also be the first in a new class of Covid-19 agents that could not only provide treatment but also potentially give temporary protection against the virus to people at risk of infection. That would fill a gap until vaccines are authorized, though people may need to take the antibody drugs more than once to sustain the protection.

"When we started this project we always believed that vaccines would be a long-term solution but that antibodies could come to patients faster," Lilly research head Daniel Skovronsky said in an interview. "We can make them faster, test them faster."

The leading experimental antibody drugs have shown enough promise in testing so far that President Trump was given one developed by Regeneron Pharmaceuticals Inc.

Regeneron said it is in talks with the Food and Drug Administration about a potential emergency-use authorization based on data it released last week showing its drug improved patients' symptoms and lowered virus levels as measured in lab tests.

Lilly said last month its drug reduced the rate of hospitalization compared with a placebo in a study. About 1.6% were hospitalized or visited the emergency room for Covid-19 after being injected with the drug, compared with 5.8% of people who didn't get the drug in the study

Antibody treatments are meant to mimic the human immune system's own agents that can neutralize the new coronavirus.

The Lilly antibody, LY-CoV555, came from a collaboration between Lilly and AbCellera Biologics Inc., of Vancouver, Canada. AbCellera isolated antibodies from a blood sample taken from one of the first people in the U.S. to recover from Covid-19. The antibody therapy is essentially a clone of one of those antibodies.

In August, Lilly started a study in nursing homes, testing whether LY-CoV555 could reduce the rate of infection and disease among vulnerable residents and staff after a case had been diagnosed at the facility.

The National Institutes of Health also has launched studies of Lilly's antibody in hospitalized and non-hospitalized Covid-19 patients.

Lilly said a new study showed that combining LY-CoV555 with another antibody reduced viral load, symptoms and hospitalizations in Covid-19 patients, compared with a placebo. The rate of Covid-19-related hospitalization and emergency-room visits was 0.9% among those who received the combination therapy, compared with 5.8% in the placebo group.

The company expects to seek emergency-use authorization for the combination in November.

The FDA said it doesn't comment on current or pending regulatory submissions.

The second antibody in the combination therapy, LY-CoV016, came from a partnership with Junshi Biosciences, of China. Each antibody targets a different region of the spike protein that is found on the surface of the new coronavirus.

The company also is in discussions with regulators outside the U.S. to potentially approve the use of its single and combination antibody therapies.

Lilly said it expects to make 50,000 doses of the combination therapy this year, and that supply would increase substantially early next year. Lilly recently formed a collaboration with Amgen Inc. to help manufacture antibodies, and Lilly said Wednesday it would pursue additional partnerships to provide the treatments to resource-limited countries.

--Joseph Walker contributed to this article.

Write to Peter Loftus at peter.loftus@wsj.com

(END) Dow Jones Newswires

October 07, 2020 16:33 ET (20:33 GMT)

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