(Reuters) – Eli Lily and Co. LLY.N said Tuesday that the government-funded clinical trial of anti-COVID-19 antibody treatment, similar to that undertaken by US President Donald Trump, has been suspended due to safety concerns.
Trump advertises the drug Lilly, along with antibody treatment from Regeneron Pharmaceuticals Inc. REGN.O that he received for his COVID-1
The announcement comes a day after Johnson & Johnson JNJ.N said he was forced to pause a major high-profile study of his experimental coronavirus vaccine because a volunteer fell ill. J&J said it did not yet know if the person had received the vaccine or a placebo.
AstraZeneca Plc AZN.L The US trial of his experimental vaccine, COVID-19, was also delayed for more than a month after a volunteer from the British study fell ill. Samples with this vaccine were resumed in other regions after a short stoppage.
Lily said earlier this month that she was applying for an Emergency Authorization (EUA) for the antibody drug, LY-CoV555, for patients with mild to moderate COVID-19 based on data from another clinical trial.
It is not uncommon for drug testing breaks to be investigated to investigate safety concerns, and such actions do not necessarily mean a serious problem. Due to the urgent need for drugs and vaccines to combat the pandemic that has claimed more than 1 million lives worldwide – and the speed at which they are evolving – these studies are under strict scrutiny.
“As a precaution, the Independent Data Safety Monitoring Board ACTIV-3 (DSMB) has recommended a pause in recording,” Lilly spokeswoman Molly McCully said in an email statement. “Lily supports the independent DSMB’s decision to cautiously ensure the safety of patients in this study.”
The Indianapolis-based drugmaker did not comment on the effects of a paused study called ACTIV-3, which is testing the treatment of patients with COVID-19 who need to be hospitalized or other ongoing studies. He is also testing the drug in nursing homes to see if it can prevent infecting staff and residents.
The US Food and Drug Administration and the National Institutes of Health did not respond immediately to requests for comment.
Lilly began her ACTIV-3 study in August and aims to recruit 10,000 patients, mostly in the United States.
The study compares patients who receive the antibody plus Gilead Sciences Inc. GILD.O Remdezivir antiviral drug with those receiving remdezivir alone.
Lily sought EUA from US regulators after publishing data in September showing that LY-CoV555 had helped reduce hospitalizations and emergency room visits for patients with COVID-19. The treatment is being developed with Canadian biotechnology AbCellera.
Shares of Lilly closed nearly 3%.
Report by Michael Herman and Carl O’Donnell in New York; Additional reporting by Deena Beasley in Los Angeles; Edited by Bill Bercrot