US suspends Eli Lilly’s trial of coronavirus antibody treatment over safety concerns

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Eli Lilly’s advanced trial of its main monoclonal antibody treatment against the coronavirus has been suspended by U.S. health regulators due to potential safety concerns, the company confirmed to CNBC on Tuesday.“Safety is of the utmost importance to Lilly. We are aware that, out of caution, the Independent Data Security Oversight Board (DSMB) ACTIV-3 has recommended a pause in registration, ”spokesperson Molly McCully told CNBC. “Lilly supports the decision of the Independent (Data Safety Monitoring Board) to prudently ensure the safety of patients participating in this study.

The ACTIV-3 assay is designed to test a monoclonal antibody developed by Eli Lilly in combination with remdesivir, an emergency-release antiviral for the virus. This is one of many ongoing trials that are part of the National Institute of Health’s “Activ” program, which is designed to accelerate the development of Covid-19 vaccines and treatments. It is also supported by Operation Warp Speed, the Trump administration’s effort to manufacture and distribute vaccines to fight Covid-19.

Eli Lilly’s drug is in a class of treatments known as monoclonal antibodies, which are designed to act like immune cells that scientists hope they can fight off the virus. The treatment was developed using a blood sample from one of the first American patients who recovered from Covid-19. AstraZeneca and Regeneron, among others, are also working on so-called antibody treatments.

Monoclonal antibody treatments made headlines this month following news that President Donald Trump had received an antibody cocktail from Regeneron Pharmaceuticals. As Trump’s health improved, he touted it as a “cure.” But Regeneron CEO Leonard Schleifer stressed that more testing was needed.

No details regarding Eli Lilly’s security issue are known yet.

“When scientists test promising treatments, sometimes unexpected side effects occur,” said Jeremy Faust, health policy expert and emergency physician at Brigham and Women’s Health.

Faust was among the group of scientists who first reported the news via the Brief19 research site.

“When only a small number of patients have received a compound, it’s hard to tell what is a real problem and what the noise is,” he told CNBC. “This is why patience and caution are always required before distributing experimental treatments. “

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