LLY Eli Lilly and Co

By Peter Loftus 

Eli Lilly & Co. said it has requested U.S. authorization of the emergency use of an experimental antibody-based treatment for people with recently diagnosed, mild-to-moderate Covid-19, following positive results from clinical testing.

The Indianapolis-based company said it is seeking the authorization for its drug, code named LY-CoV555, which was derived from a blood sample of one of the earliest U.S. survivors of Covid-19.

If cleared, it 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., target hospitalized patients with more serious cases.

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.

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

Lilly said last month its drug reduced the rate of hospitalization compared with a placebo in a study.

The Indianapolis company is manufacturing doses and could have 100,000 doses this month and as many as one million by the end of the year.

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.

Lilly also 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 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.

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

(END) Dow Jones Newswires

October 07, 2020 10:08 ET (14:08 GMT)

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