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

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, known as a DSMB, for the trial 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.

An spokeswoman for the National Institute of Allergy and Infectious Diseases, which is sponsoring the study, didn't immediately comment.

Lilly's drug is essentially a clone of immune-system agents known as antibodies, which fight infections.

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.

Last week, Lilly asked the Food and Drug Administration to authorize emergency use of the antibody in non-hospitalized 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.

Write to Peter Loftus at [e-mail]

(END) Dow Jones Newswires

October 13, 2020 15:44 ET (19:44 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.