The United States government has paused the clinical trial being conducted by Eli Lilly and Co because of safety concerns, the company said. The trial was for an antibody treatment of Covid-19, the one taken by US President Donald Trump, and is being sponsored by the US government.
In a video posted by Trump last week, the treatment of Lilly as well as the antibody treatment from Regeneron Pharmaceuticals Inc that was administered to him were praised and were touted to be almost a cure for the disease.
Just a day ago, the large high-profile trial of its experimental coronavirus vaccine was paused by Johnson & Johnson after one of the participants of the trial feel sick because of unexplained reasons. It is not yet known whether that participant was given the vaccine or a placebo, J&J said.
It has also been more than a month that last stage trial for its Covid-19 vaccine candidate has been put on hold in the United States by AstraZeneca Plc after one of the volunteers of the trials feel sick in the United Kingdom. The company has resumed its trials in other parts of the world.
An application for emergency use authorization (EUA) for the antibody drug, LY-CoV555, targeted at patients with mild to moderate Cvoid-19 symptoms would be filed by it, Lilly said earlier this month. This was based on data from another clinical trial.
Temporary halting of drug trials for investigating safety concerns is not uncommon and such incidents are not generally indications of any serious problems in the drugs or vaccines. However, the speed of the trials for Covid-19 has come under intense scrutiny as governments around the world have speeded up the trials for Cvoid-19 vaccine candidates due to the urgent need for drugs and vaccines to tackle a pandemic that has claimed over 1 million lives globally.
“Out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” 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.”
No comments on implications for the paused trial, called ACTIV-3, were made by the Indianapolis-based drug maker. ACTIV-3 is being tested on Covid-19 patients who require hospitalization. The company is also conducting tests of the drug in nursing homes to see if it can prevent staff and residents from getting infected.
The National Institute of Allergy and Infectious Diseases (NIAID), a division of National Institutes of Health (NIH) of the US is partnering with Lilly in this trial.
The recommendations of the data and safety monitoring board formed the basis of the suspension of the trials, NIAID said.
No comments were available on the issue from the US Food and Drug Administration.
Started in August, the ACTIV-3 trial aims to recruit 10,000 patients primarily in the United States.
(Adapted from IndianExpress.com)