The paused trial, which Lilly calls ACTIV-3, focused on hospitalized patients. Lilly said it differed from its other trials in some key respects, including the fact that the patients had more serious illness and were being treated with other drugs, including Gilead Sciences Inc’s remdesivir.
Lilly said in a statement that neutralizing antibody drugs such as bamlanivimab, which it is studying in COVID-19 patients, may be less beneficial for hospitalized patients than for those with more mild cases of the disease.
The trial was paused at the request of an oversight board, called a Data Safety and Monitoring Board (DSMB), which also reviews data on other U.S. government-backed studies of COVID-19 medicines. It is not uncommon to pause drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem.
“Lilly trusts the judgment of the independent DSMB and supports its decisions to exercise caution in ensuring the safety of the patients participating in this study,” the company said in a statement.
Lilly said on Tuesday the government-sponsored clinical trial of its COVID-19 antibody treatment, which is similar to one taken by U.S. President Donald Trump, had been paused over safety concerns.
Lilly said earlier this month it was applying for emergency use authorization (EUA) for the antibody-drug, also called LY-CoV555, for patients with mild to moderate COVID-19 based on data from another clinical trial. It is also testing the drug in nursing homes to see if it can prevent staff and residents from getting infected.View link »