DM Monitoring
WASHINGTON: U.S. drugmaker Eli Lilly said Tuesday it has paused its trial of a combination antibody treatment for COVID-19 for safety reasons.
The company said the trial’s Data Safety Monitoring Board (DSMB), an independent group of medical experts who monitor clinical trials, recommended the pause.
“The trial, evaluating Lilly’s investigational neutralizing antibody as a treatment for COVID-19 in hospitalized patients, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH),” a Lilly spokesperson said in a statement.
“Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study,” said the statement.
Neither Eli Lilly nor the NIAID, which is sponsoring the trial, have described the safety issue that prompted the decision to pause the study.
The study is one of several being conducted in the United States to test the use of the antibody treatment in various settings.
Eli Lilly announced earlier this month that new data showed that combination therapy with two of Lilly’s SARS-CoV-2 neutralizing antibodies reduced viral load, symptoms and COVID-related hospitalization and emergency room visits.
The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555 and LY-CoV016, which bind complementary regions of the SARS-CoV-2 spike protein, for the treatment of symptomatic COVID-19 in the outpatient setting.
The combination cohort enrolled recently diagnosed patients with mild-to-moderate COVID-19, who were assigned to 2,800 mg of each antibody or placebo.
The company said it has submitted request for emergency use authorization (EUA) for monotherapy to the U.S. Food and Drug Administration.
