(Reuters) – Eli Lilly and Co LLY.N said Tuesday that the government-sponsored clinical trial of his COVID-19 antibody treatment similar to that taken by US President Donald Trump has been suspended due to safety concerns.
Trump advertised the Lilly drug, along with Regeneron Pharmaceuticals Inc’s antibody treatment KINGDOM which he received for his COVID-1
The announcement comes a day after Johnson & Johnson JNJ.N said he was forced to suspend a large high-profile study of his experimental coronavirus vaccine because a volunteer fell ill. J&J said he still doesn’t know if that person was given the vaccine or a placebo.
AstraZeneca Plc’s AZN.L The US trial for his investigational COVID-19 vaccine was also suspended for over a month after a volunteer from his UK study fell ill. Trials of that vaccine resumed in other regions after a short break.
Lilly said earlier this month that she was seeking emergency use authorization (EUA) for the antibody drug, LY-CoV555, for patients with mild to moderate COVID-19 based on data from another. clinical study.
It is not uncommon to pause drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem. Due to the urgent need for drugs and vaccines to tackle a pandemic that has claimed over 1 million lives worldwide and the speed at which they are being developed, these studies have come under scrutiny.
“Out of an abundance of caution, the independent data security monitoring committee (DSMB) ACTIV-3 has recommended a pause in recording,” Lilly spokesperson Molly McCully said in an e-mailed statement. “Lilly supports the independent DSMB’s decision to cautiously ensure the safety of patients participating in this study.”
The Indianapolis-based drug manufacturer did not comment on the implications for the paused study, called ACTIV-3, which is testing the treatment on COVID-19 patients requiring hospitalization, or on other ongoing studies. It is also testing the drug in nursing homes to see if it can prevent infection of staff and residents.
The US Food and Drug Administration and the National Institutes of Health did not immediately respond to requests for comment.
Lilly began her ACTIV-3 trial in August and aims to recruit 10,000 patients primarily in the United States.
The study compares patients receiving its antibody drug plus that of Gilead Sciences Inc. GILD.O antiviral drug remdesivir with those receiving remdesivir alone.
Lilly searched the EUA from US regulators after they released data in September that showed LY-CoV555 helped reduce hospitalization and emergency room visits for COVID-19 patients. The treatment was developed with Canadian biotechnology AbCellera.
Lilly shares closed nearly 3%.
Reportage by Michael Erman and Carl O’Donnell in New York; Additional reporting by Deena Beasley in Los Angeles; Editing by Bill Berkrot