NIH Halts Study Exploring Treating Covid-19 With Lilly Antibody, Remdesivir
The study, paused due to a safety concern, won’t resume because the combination drug treatment didn’t show any signs of benefitFederal health researchers have halted testing a combination of Eli Lilly LLY & Co.’s Covid-19 antibody drug and remdesivir in hospitalized Covid-19 patients, after an independent committee found a lack of a benefit.
The National Institute of Allergy and Infectious Diseases, which is funding the study, said Monday it was planning to test other experimental drugs as Covid-19 treatments in the study. Lilly said it would continue testing its antibody drug in other studies, in patients earlier in the course of their disease, and in people at risk of infection.
The decision may not affect the U.S. Food and Drug Administration’s appraisal of Lilly’s antibody drug, which is up for authorization as a solitary treatment for patients with mild to moderate Covid-19 and not hospitalized.Enrollment in the study of the drug combination had been paused earlier this month due to a potential safety concern.
An independent board overseeing the trial found a difference in the clinical status between Covid-19 patients who received the Lilly drug and those who got a placebo.NIAID had said it ordered the pause out of an abundance of caution, and Lilly said it supported the move to ensure patient safety.
After reviewing updated data from the study, however, the independent board on Monday found no significant differences in safety outcomes between patients getting the Lilly drug and those on placebo.Instead, the board’s decision to recommend that no further patients be given the Lilly drug in the study “was driven by lack of clinical benefit” in hospitalized patients, NIAID said.Some 326 patients had been enrolled in the study, and researchers will continue to follow them for 90 days.Lilly’s drug, code named LY-CoV555, is essentially a clone of immune-system agents known as antibodies that fight infections.Lilly is codeveloping the drug with AbCellera Biologics Inc., of Vancouver, Canada, which isolated antibodies from a blood sample taken from one of the earliest Americans to recover from Covid-19.
The trial testing whether adding LY-CoV555 to Gilead Sciences Inc.’s GILD -1.37% remdesivir would benefit people hospitalized with Covid-19 began in August. Remdesivir is approved to treat serious hospitalized Covid-19 patients.
The trial’s close is a setback in efforts to find better treatments for Covid-19, but Lilly said the drug continues to have potential to help people at earlier stages of Covd-19 than hospitalized patients.Lilly said Monday all other studies of LY-CoV555 are still ongoing, including in nonhospitalized patients and residents and staff at long-term care facilities.
The Indianapolis-based company also said that while there was insufficient evidence that its drug improved clinical outcomes in hospitalized patients, it was confident that the drug may prevent progression of disease for those earlier in the course of Covid-19.
A separate study testing the drug alone found that it reduced hospitalizations in patients with mild to moderate forms of the disease.Based on that study, Lilly asked the FDA earlier this month to authorize emergency use of the antibody in nonhospitalized people with recently diagnosed mild-to-moderate Covid-19.
Wall Street Journal
https://www.wsj.com/articles/nih-halts-study-exploring-treating-covid-19-with-lilly-antibody-remdesivir-11603757478
(20min delay)