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.
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The National Institute of Allergy and Infectious Diseases, which is sponsoring the study, said Tuesday that 326 patients had been enrolled before the study was temporarily paused at the recommendation of an independent board.
In a statement, NIAID said the board made the recommendation after a scheduled analysis of safety data for the first 300 patients enrolled in the study found “an overall difference in clinical status between the group receiving LY-CoV555 and the group receiving saline placebo.”
In addition to pausing enrollment, the safety board recommended continuing data collection and follow-up of current participants for safety and efficacy. The board will review data again at a planned meeting on Oct. 26, and will make a recommendation on whether enrollment should resume, NIAID said.
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 drugs can cause sensitivity or immune reactions after being infused. 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.
Janet Woodcock, director of the Food and Drug Administration’s Center for Drug Evaluation and Research, said last week that she wouldn’t expect antibody drugs to have potential harmful interactions with antiviral drugs like remdesivir.
“Their mechanism of action is totally different,” Dr. Woodcock, who is detailed to the federal government’s drug and vaccine accelerator Operation Warp Speed, said in a conference call with reporters. “And the monoclonal antibodies being biological products are not going to have the kind of drug-drug interactions that you would see with two small molecules—for example, dexamethasone and hydroxychloroquine, where we have seen some interaction.”
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.
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