October 13, 2020 By [email protected]_84 Off

Are Antibody Infusions Safe? Eli Lilly Pauses COVID Treatment Trial

KEY POINTS

  • Eli Lilly did not say what symptoms the ill patient developed
  • President Trump was given an antibody cocktail as part of his COVID treatment
  • AstraZeneca earlier paused it’s vaccine trial but has since restarted it in the U.K.

 

Eli Lilly (LLY) on Tuesday paused its coronavirus antibody trial because of a potential safety concern just one day after Johnson & Johnson (JNJ) paused its COVID-19 vaccine trial because of an unexplained illness.

The New York Times reported emails between Lilly and federal government officials concerned the trial testing the benefits of the antibody therapy on hundreds of hospitalized COVID-19 patients. All study patients also were receiving Gilead’s (GILD) trial remedy Remdesivir.

The Times said no details were provided on the number of volunteers who fell ill or any details about their illnesses.

Last week, Lilly reported just two test subjects had serious infusion reactions.

President Donald Trump received antibody therapy after he was diagnosed with COVID-19 but was given the drug cocktail developed by Regeneron (REGN). He received Remdesivir and the powerful steroid dexamethasone, as well.

Enrollment in the Eli Lilly trial was sponsored by the National Institutes of Health, the Department of Veterans Affairs and other agencies. Emails obtained by the Times Tuesday indicated the trial was being paused out of an “abundance of caution.”

“Safety is of the upmost importance to Lilly,” spokeswoman Molly McCully told the Times in an email. “Lilly is supportive of the decision by the independent [Data and Safety Monitoring Board] to cautiously ensure the safety of the patients participating in this study.”

Antibodies can prevent the virus from infecting cells and may reduce a person’s symptoms.

The pause comes one day after J&J said one of the subjects in its 60,000-subject trial came down with an unexplained illness. It was unclear whether the person had received the vaccine or a placebo.

Earlier, AstraZeneca briefly paused its vaccine trial for the same reason. Company CEO Pascal Soriot told investors a woman experienced neurological symptoms consistent with the spinal inflammatory disorder transverse myelitis, which interrupts messages from spinal cord nerves, causing pain, abnormal sensations, arm and leg weakness, and bladder and bowel problems. Trials have resumed in the U.K. The U.S. portion of the trial has yet to be restarted.

Eli Lilly shares were off $5.03 or 3.26% at $149.44 at 3:50 p.m. EDT.

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