The US suspends Eli Lilly's try at remedy with coronavirus antibodies over security issues


In this May 2020 photo by Eli Lilly, researchers prepare mammalian cells to produce potential COVID-19 antibodies for testing in an Indianapolis laboratory.

David Morrison | Eli Lilly on AP

Eli Lilly's late-stage study of its leading monoclonal antibody treatment to the coronavirus has been suspended by U.S. health officials over possible safety concerns, the company confirmed to CNBC on Tuesday.

"Security is of the utmost importance to Lilly. We understand that the ACTIV-3 Independent Data Security Supervisory Board (DSMB) has cautionarily recommended suspending registration," a spokeswoman Molly McCully told CNBC. "Lilly supports the decision of the independent (Data Safety Monitoring Board) to carefully ensure the safety of the patients participating in this study.

The ACTIV-3 study was designed to test a monoclonal antibody developed by Eli Lilly in combination with remdesivir, an antiviral agent with an emergency approval for the virus. It is one of several ongoing studies that are part of the National Institute of Health's "Activ" program aimed at accelerating the development of Covid-19 vaccines and treatments. It is also backed by Operation Warp Speed, the Trump administration's efforts to manufacture and distribute vaccines to fight Covid-19.

Eli Lilly's drug is in a class of treatments known as monoclonal antibodies, which act as immune cells that scientists hope can fight the virus. The treatment was developed using a blood sample from one of the first U.S. patients to recover from Covid-19. AstraZeneca and Regeneron are also working on so-called antibody treatments, among other things.

Monoclonal antibody treatments made headlines this month after it was revealed that President Donald Trump had received an antibody cocktail from Regeneron Pharmaceuticals. As Trump's health improved, he touted it as a "cure". However, Regeneron's CEO Leonard Schleifer has stressed that more testing is needed.

No details are known yet about Eli Lilly's security concerns.

"When scientists test promising treatments, sometimes unexpected side effects occur," said Jeremy Faust, health policy expert and emergency medicine specialist at Brigham and Women's Health.

Faust was part of the group of scientists who first reported the news through the Brief19 research site.

"When only a small number of patients have been connected, it's hard to tell what's a real problem and what's noise," he told CNBC. "Therefore, patience and caution are always required before experimental treatments are distributed."


Steven Gregory