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Drugmaker Pauses Trial of COVID Antibody Treatment

Eli Lilly says it's for safety reasons, without elaborating
By Jenn Gidman,  Newser Staff
Posted Oct 14, 2020 7:31 AM CDT

(Newser) – Drugmaker Eli Lilly, working to come up with an antibody treatment for COVID-19, has paused its phase three clinical trials after an independent data safety monitoring board (DSMB) raised concerns. "Safety is of the utmost importance to Lilly," a company spokeswoman said in a statement Tuesday, reports CNBC. "Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study." As part of Eli Lilly's ACTIV-3 trials, the monoclonal antibody—a combo of two lab-produced proteins that boost the immune system by neutralizing the coronavirus— is used alongside the antiviral remdesivir. The treatment is said to be similar to one by Regeneron that President Trump received to treat his own bout with the virus.

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The Eli Lilly rep didn't elaborate on exactly why the trials were paused. But the National Institutes of Health said late Tuesday it was because the study had reached a "predefined boundary for safety," meaning either a group of subjects that received the treatment or those who received a placebo had crossed that threshold, though the NIH didn't say which, per a STAT release. CNN notes trials are usually suspended when a volunteer becomes sick or suffers some other sort of side effect. Still, medical experts say this type of hiccup during clinical trials isn't unusual, and that bad reactions to drugs can sometimes arise from other, unrelated illnesses, not from the actual drug, per CNBC. Eli Lilly's treatment received a shoutout from Trump in early October, after he'd been treated. "We have these drugs, Eli Lilly and the others that are so good," he said. (Read more Eli Lilly stories.)

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