Study of Eli Lilly Covid-19 Drug Paused Due to Safety Concern -- Update

By Peter Loftus 

A federally funded clinical trial testing an experimental Eli Lilly & Co. Covid-19 treatment has been paused due to a potential safety concern, the company said.

The study, which started in August, was testing whether adding Lilly's antibody-based drug, LY-CoV555, to Gilead Sciences Inc.'s remdesivir would benefit people hospitalized with Covid-19.

Indianapolis-based Lilly said Tuesday that an independent data safety monitoring board for the trial, known as a DSMB, recommended a pause in enrollment out of an abundance of caution.

"Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study, " the company said. The company didn't release additional details about the nature of the safety concern.

A spokeswoman for the National Institute of Allergy and Infectious Diseases, which is sponsoring the study, didn't immediately comment. A Gilead spokesman declined to comment.

Lilly's drug is essentially a clone of immune-system agents known as antibodies, which fight infections. A study testing the drug alone found that it reduced hospitalizations in patients with mild to moderate forms of the disease.

Testing of the antibody drug combined with remdesivir is being conducted at sites in the U.S., Denmark and Singapore.

Lilly and the National Institutes of Health also are conducting other studies of the antibody, which are ongoing.

Last week, Lilly asked the Food and Drug Administration to authorize emergency use of the antibody in nonhospitalized people with recently diagnosed mild-to-moderate Covid-19. The company cited a study showing the drug reduced the rate of hospitalization for patients.

The pause is the latest affecting Covid-19 pharmaceutical testing. J&J said late Monday it was suspending trials exploring its Covid-19 vaccine after a subject got sick.

Lilly has co-developed its Covid-19 antibody drug with AbCellera Biologics Inc., of Vancouver, Canada, which isolated the antibody from a blood sample taken from one of the first people in the U.S. to recover from Covid-19.

Regeneron Pharmaceuticals Inc. and others are testing similar antibody-based drugs for Covid-19. They hold potential not only to treat sick patients, but also to prevent Covid-19 in people at risk of infection. If successful, they could serve as a bridge until a Covid-19 vaccine is developed.

Monoclonal antibody drugs haven't been studied extensively in Covid-19 patients, but the most common side effects have been sensitivity or immune reactions to the drug. Remdesivir is a more traditional pharmaceutical drug that has a different mechanism of action than antibodies, and isn't yet known to have negative interactions. Remdesivir requires patients' liver and kidneys to be monitored.

The combination of Lilly's antibody with remdesivir is similar to a portion of the treatment provided to President Donald Trump for his case of Covid-19 earlier this month. The president didn't receive Lilly's antibody but rather an antibody-based treatment from Regeneron, followed by remdesivir and the steroid dexamethasone.

In August, Lilly started a separate study exploring whether the antibody can prevent infections among vulnerable residents and staff at nursing homes and other long-term care facilities.

Write to Peter Loftus at [e-mail]

(END) Dow Jones Newswires

October 13, 2020 17:37 ET (21:37 GMT)

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