An independent data safety monitory board (DSMB) recommended the drugmaker pause enrollment as “an abundance of caution.”
The NIH-sponsored study is testing bamlanivimab (LYCoV555) in combination with Gilead’s remdesivir in hospitalized patients. About 300 patients had been enrolled before the trial was stopped.
In a statement, Lilly said it “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.” Lilly gave no further details about the nature of the safety concern.
Currently, only the DSMB has reviewed data from the trial and both the NIH’s leadership and Lilly remain blinded to the ongoing results. If the study gets the green light to resume, then it will enroll another 700 patients, including those who may need supportive care for organ failure.
The stalled trial has not affected other studies that Lilly and the NIH are conducting on the antibody, including a Phase 2 trial in patients recently diagnosed with mild to moderate Covid-19 and a couple of studies on ambulatory patients and as a preventive treatment.
Reporting early Phase 2 data last month, Lilly said the treatment reduced hospitalizations in patients with mild to moderate Covid-19 – the pharma group has since requested emergency authorization from the Food and Drug Administration.
The halt in Lilly’s trial is the third in recent weeks and comes just a day after Johnson & Johnson had to stop its Phase 3 study on a Covid-19 vaccine because a patient became unwell with an “unexplained illness.”
Last month, AstraZeneca put on hold its Phase 3 trial of vaccine candidate AZD1222 after a UK participant developed a neurological illness. The Anglo-Swedish drugmaker has since resumed studies in the UK, Brazil, South Africa, India and Japan but trials in the US remain halted for reasons unknown.
Author: Elaine Burridge, Freelance Journalist
