Eli Lilly & Co. won't proceed with its clinical trials after U.S. government officials concluded an experimental vaccine it is developing doesn't seem to be helping hospitalized COVID patients with serious infections.
The National Institute of Allergy and Infectious Diseases, which sponsors the research, said an in-depth evaluation didn't confirm any safety issues but found a very low chance the treatment would prove useful. The halt in trials comes two weeks after Eli Lilly put on hold a trial citing a possible safety concern.
Antibody treatments are currently being developed by a handful of biotech groups, including AstraZeneca, GlaxoSmithKline PLC and Regeneron Pharmaceuticals. The category of therapies has made headlines as U.S. President Donald Trump was administered with Regeneron's candidate antibody vaccine to treat his COVID infection. Former New Jersey Gov. Chris Christie said he was treated with Eli Lilly's potential vaccine when he was hospitalized for COVID this month.
The decision by federal researchers to suspend trials may not affect the U.S. Food and Drug Administration's examination of Eli Lilly's antibody drug, which is awaiting authorization as an independent therapy for non-hospitalized patients suffering mild to moderate symptoms of the virus.
The order to pause, NIAID said, was out of an abundance of caution and Eli Lilly said it was in favor of the action to ensure safety among patients. Some 326 patients had participated in the trials and scientists said they would continue to monitor them for three months.
The disclosure is a sign that monoclonal antibodies may only prove effective if given early in the course of a COVID infection before it has had the momentum to attack the lungs and cause extensive damage.
The Indianapolis-based biotech giant's vaccine is basically a duplicate of immune-system agents that researchers refer to as antibodies that protect against the onslaught of infections.
Eli Lilly said it would push forward with other tests for its potential COVID vaccine - including a second-stage trial for non-hospitalized patients who recently tested with the disease and a third-stage test for the prevention of the virus in residents and personnel at long-term care health centers.
