Eli Lilly pauses study of COVID-19 treatment over safety concerns

Eli Lilly’s late-stage clinical trial of a monoclonal antibody treatment for COVID-19 has been paused by federal regulators due a safety concern, the company said Tuesday.

“Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” spokeswoman Molly McCully told The Hill in an emailed statement. 

“Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study,” McCully added. 

She did not provide any information about what caused the panel to recommend the pause or how long it might last.

The clinical trial is designed to evaluate Lilly’s neutralizing antibody as a treatment for COVID-19 in hospitalized patients in combination with the antiviral drug remdesivir. It is being tested against a combination of remdesivir and a placebo. 

The trial is sponsored by the National Institute of Allergy and Infectious Diseases as well as the Trump administration’s Operation Warp Speed.

Thus far, more than 850 trial participants have been dosed, but the company said data from the trial is not yet available.

Monoclonal antibodies are lab-generated versions of one of the human body’s main defenses against pathogens.

AstraZeneca and Regeneron, among other companies, are also working on antibody treatments.

The use of antibodies to treat COVID-19 made headlines in the past week after President Trump said he received an antibody cocktail from Regeneron, and touted it as a “miracle” and a “cure.” 

There’s no evidence Regeneron’s antibody therapy was responsible for Trump’s apparent recovery, and antibodies are not a cure for COVID-19. 

Doctors and health experts think antibody drugs could be a bridge to a COVID-19 vaccine but have cautioned that the results to date are very preliminary and that longer studies are needed.

Trump has said the treatments will be approved shortly by the Food and Drug Administration and will be widely available to the public for free. Both Lilly and Regeneron have applied for emergency use authorization for their products, but both are intended for nonhospitalized patients with mild cases of COVID-19.