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 Lillys The U.S. Health Inspectorate has stopped U.S. health officials over possible late-stage safety concerns in their lead monoclonal antibody treatment to the coronavirus. This was confirmed by 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 DSMB to carefully ensure the safety of the patients participating in this study.”
The company’s shares fell about 3% in afternoon trading after the news hit Twitter.
The news comes less than 24 hours later Johnson & Johnson confirmed that its The late-stage coronavirus vaccine trial has been suspended after a participant reported an “adverse event” the day before.
Dr. Mathai Mammen, Janssen’s global director of research and development at J & J, told investors on a conference call Tuesday that the company still had “very little information” about the reason for the delay, even if the patient had the vaccine or received the placebo. Preliminary information has been sent to the data security watchdog for review, he added.
Medical experts note that breaks are not uncommon in large clinical trials. They added that it is possible that the bad response was due to an unrelated disease, and not the drug itself. The review by the Data and Safety Oversight Panel will help determine this.
The ACTIV-3 study was designed to test a monoclonal antibody developed by Eli Lilly in combination with Gilead Sciences’ 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 Regeneronwork, among other things, on so-called antibody treatments.
Monoclonal antibody treatments made headlines this month after the president was briefed Donald Trump 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.
Trump has previously touted Eli Lil’s treatment and others. Earlier this month, when he got Covid-19, he said, “We have these drugs, Eli Lilly and the others that are so good.”
“They are in my opinion, remember, they will say they are therapeutic. And I think they are therapeutic. Some people don’t know how to define therapeutic. I see it differently. It’s a cure.” Trump said in a video posted on Twitter October 7th. “I walked in for me. I didn’t feel good. A short 24 hours later, I felt great. I wanted out of the hospital. And that’s it.” What I want for everyone. I want everyone to get the same treatment as your president because I feel great. “
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 via the Brief19 research page.
“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.”
CNBC’s Kevin Stankiewicz contributed to this report.