COVID-19 antibody study paused over possible safety issue


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Independent monitors have paused enrolment in a study testing the COVID-19 antiviral drug remdesivir plus an experimental antibody therapy being developed by Eli Lilly that’s similar to a treatment U.S. President Donald Trump recently received.

Eli Lilly confirmed Tuesday that the study had been paused “out of an abundance of caution,” and said safety is its top concern. The company would not say more about what led to this step.

The U.S. National Institute of Allergy and Infectious Diseases, which sponsors the study, would not immediately comment.

Antibodies are proteins the body makes when an infection occurs; they attach to a virus and help eliminate it. The experimental drugs are concentrated versions of one or two specific antibodies that worked best against the coronavirus in lab and animal tests.

This study was testing a single antibody that Eli Lilly is developing with the Canadian company AbCellera. Trump received an experimental two-antibody combo drug from Regeneron Pharmaceuticals Inc.

Eli Lilly and Regeneron have asked the U.S. Food and Drug Administration to grant emergency use authorization for their drugs to treat COVID-19 while late-stage studies continue.

The paused study, called ACTIV-3, started in August and aims to enrol 10,000 hospitalized COVID-19 patients in the United States, Denmark and Singapore. All would be given remdesivir, which has been authorized in the U.S. as an emergency treatment for COVID-19, plus either the Eli Lilly antibody or a placebo.

The main goals are reducing the need for extra oxygen and the time to recovery. Deaths, relief of symptoms and other measures also are being tracked. All of the drugs are given through an IV.

Such pauses are not uncommon in long clinical studies. Unlike a study hold imposed by government regulators, a pause is initiated by the sponsor of the drug trial and often can be quickly resolved.

2nd vaccine Phase 3 trial halted due to ‘unexplained illness’ of participant

The pause in the Eli Lilly study comes a day after a temporary halt to enrolment in a coronavirus vaccine study. Johnson & Johnson executives said Tuesday that it will be a few days before they know more about an unexplained illness in one participant that caused a pause in its late-stage vaccine study. Johnson & Johnson isn’t disclosing the nature of the illness.

“It may have nothing to do with the vaccine,” said Mathai Mammen, head of research and development for Janssen, Johnson & Johnson’s medicine development business.

Mammen said the company doesn’t know yet whether the ill participant received the experimental vaccine or a dummy shot. He says Johnson & Johnson gave information on the case to the independent monitoring board overseeing the safety of patients in the study, as the research protocol requires. It will recommend next steps.

The study of the one-dose vaccine will include up to 60,000 people from multiple countries. The company expects to complete enrolment in the study in two or three months.

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