Eli Lilly and Co LLY.N said on Tuesday that the government-sponsored clinical trial of its COVID-19 antibody treatment like one taken by U.S. President Donald Trump has been paused because of a safety concern.
Trump touted the Eli Lilly drug, along with the antibody treatment from Regeneron Pharmaceuticals Inc REGN.O that he received for his COVID-19, as tantamount to a cure in a video he posted last week.
Another pharmaceutical company halted testing of experimental COVID-19 drug treatment because of safety concerns.
U.S.-based Eli Lilly and Company announced Tuesday that the clinical trial of its coronavirus antiviral drug had been caused by independent monitors “out of an abundance of caution,” but did not go into details.
The drug, which Eli Lilly is developing with Canadian-based biotech firm AbCellera, is part of a class of treatments known as monoclonal antibodies, which are made to act as immune cells that scientists hope can fight off the virus. The antibody therapy was similar to one given to U.S. President Donald Trump after he tested positive for COVID-19 earlier this month.
The study, which launched in August, aimed to enroll 10,000 hospitalized coronavirus patients in the United States.
Eli Lilly applied to the U.S. Food and Drug Administration for emergency authorization for the drug to be used for mild to moderate cases of COVID-19 infections based on preliminary results from a different clinical trial.
Eli Lilly said earlier this month it was applying for emergency use authorization (EUA) for the antibody-drug, LY-CoV555, for patients with mild to moderate COVID-19 based on data from another clinical trial.
It is not uncommon to pause drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem. Because of the urgent need for drugs and vaccines to tackle a pandemic that has claimed over 1 million lives worldwide – and the speed with which they are being developed – these trials have come under intense scrutiny.
“Out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” Eli Lilly spokeswoman Molly McCully said 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.”
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