Trial of Eli Lilly antibody treatment is paused for potential safety concerns

A government-sponsored clinical trial testing an antibody treatment made by the drug company Eli Lilly has been paused because of a “potential safety concern,” according to emails that government officials sent on Tuesday to researchers at testing sites, and confirmed by the company.

The news comes just a day after Johnson & Johnson announced the pause of its coronavirus vaccine trial because of a sick volunteer, and a month after AstraZeneca’s vaccine trial was halted over concerns about two participants who had fallen ill after getting the company’s vaccine.

The Eli Lilly trial was designed to test the benefits of the therapy on hundreds of people hospitalized with COVID-19, compared with a placebo. All study participants also received another experimental drug, remdesivir, which has become commonly used to treat patients with COVID-19. It is unclear how many volunteers were sick, or any details about their illness.

In large clinical trials, such pauses are not unusual, and illness in volunteers is not necessarily the result of the experimental drug or vaccine. Such halts are meant to allow an independent board of scientific experts to review the data and determine whether the event may have been related to the treatment, or occurred by chance.

Enrolment for the Eli Lilly trial, which was sponsored by several branches of the National Institutes of Health and the Department of Veterans Affairs, among others, had been ongoing. But emails sent Tuesday from multiple officials told researchers to stop adding volunteers to the study out of an “abundance of caution.”

In a statement sent over email, Molly McCully, a spokeswoman for Eli Lilly, confirmed the pause. “Safety is of the upmost importance to Lilly,” she said. “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study,” referring to the Data and Safety Monitoring Board.

The NIH and the VA did not immediately respond to requests for comment.

Eli Lilly is one of several companies pursuing experimental treatments for COVID-19 that use monoclonal antibodies — mass-produced mimics of immune molecules the human body produces in reaction to the virus.

Eli Lilly’s product is similar to a treatment designed by drug company Regeneron, which developed an antibody therapy given to President Donald Trump after he was diagnosed with COVID-19 earlier this month. Trump has promoted the treatments, without evidence, as a “cure” for his condition, and has suggested that their approval and widespread distribution could be imminent. The week after the president was treated, both companies applied for emergency clearance for their products from the Food and Drug Administration.

Antibodies can block the coronavirus from infecting cells, and preliminary data from Eli Lilly and Regeneron have hinted they may be able to tamp down the amount of virus in an infected person’s body and reduce their symptoms.

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