Health Care

Covid-19 coronavirus: Possible safety issue spurs pause of antibody study

The Eli Lilly trial was created to test the benefits of the therapy on hundreds of people hospitalized with COVID-19, compared with a placebo.

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.

The problem has not been identified, but the company says safety is its top priority.

Neither Eli Lilly nor the NIAID, which is sponsoring the trial, have described the safety issue that prompted the decision to pause the study.

Two late-stage COVID-19 medical trials have been paused in the space of 24 hours over potential safety concerns, the latest setbacks to scientists in the long fight against the pandemic.

The pause in the Lilly study comes a day after a temporary halt to enrollment in a coronavirus vaccine study.

During the call, the company said it did not know whether the participant had received the vaccine or a placebo, according to press reports.

Such pauses for large clinical trials can occur and don't necessarily mean anything is wrong with the treatment.

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Enrollment for the Eli Lilly trial, which was sponsored by several branches of the National Institutes of Health and the Department of Veterans Affairs, among others, had been ongoing.

An independent data safety monitoring board recommended pausing enrollment in the USA government-sponsored trial, a company spokeswoman said in a statement. "Lilly is supportive of the decision by the independent (Data Safety Monitoring Board) to cautiously ensure the safety of the patients participating in this study". It's also testing an antibody cocktail.

The US Food and Drug Administration and the National Institutes of Health did not immediately reply to requests for comment.

The treatment is being developed with Canadian biotech AbCellera.Lilly shares closed almost 3%.

The study began in August across more than 50 sites in the United States, Denmark and Singapore with the aim of recruiting 10,000 people. The 300-participant trial known as ACTIV-3 will also treat patients in both the placebo arm and antibody arm with Gilead Sciences Inc.'s antiviral remdesivir, which is considered to be a standard of care.

The ACTIV-3 trial is created to test a monoclonal antibody developed by Eli Lilly in combination with remdesivir, an antiviral medication with emergency use authorization for the virus, the report said.

Lilly sought the EUA from USA regulators after publishing data in September showing LY-CoV555 helped cut hospitalisation and emergency room visits for COVID-19 patients.

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