Health Care

Second Covid-19 trial paused within 24 hours over safety concerns

Second Covid-19 trial paused within 24 hours over safety concerns”

USA pharmaceutical firm Eli Lilly on Tuesday paused a late-stage trial of its experimental lab-produced antibody treatment against Covid-19 over an unspecified safety concern, the company said. Lilly didn't provide information about what caused the panel to recommend the pause.

If Lilly's treatment gets the green light, the study will enroll another 700 patients, including sicker ones who may need supportive care for organ failure.

The clinical trial is created to evaluate Lilly's neutralizing antibody as a treatment for COVID-19 in hospitalized patients in combination with the antiviral drug remdesivir. Scientists work with a bioreactor at a Regeneron facility in NY state, for efforts on an experimental coronavirus antibody drug.

The announcement comes one day after Johnson & Johnson said it was forced to pause a large high-profile trial of its experimental coronavirus vaccine because a volunteer fell ill.

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

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News of the pause in the ACTIV-3 trial was first reported by the New York Times, citing emails that government officials sent to researchers at testing sites. 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. A final decision must be made by the monitoring board before any future action is taken.

It was not immediately clear whether the pause would affect other clinical trials that Lilly is running for Covid-19, for example among patients with mild to moderate forms of the disease or as a potential prophylaxis.

The company said it has submitted request for emergency use authorization (EUA) for monotherapy to the U.S. Food and Drug Administration. The BLAZE-1 trial is testing the monotherapy and the combination therapy in patients with early symptoms of Covid-19 who have not been hospitalized.

Lilly serves as the primary sponsor on that trial, collaborating with its co-developer on the LY-CoV555 antibody therapy, Canadian biotech AbCellera Biologics Inc.



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