Eli Lilly and Co. (LLY) will end a phase III clinical trial for its COVID-19 antibody treatment in the U.S., due to insufficient evidence on improved clinical outcomes.
Lilly noted that no additional COVID-19 patients in the hospitalized setting will receive the company's investigational monoclonal antibody LY-CoV555 or bamlanivimab. The recommendation was based on trial data suggesting that LY-CoV555 is unlikely to help hospitalized COVID-19 patients recover from the advanced stage of their disease.
The move comes two weeks after it paused the trial due to a potential safety concern.
In mid October, reports said that a phase III trial evaluating Eli Lilly's investigational monoclonal antibody LY-CoV555 in combination with standard of care Gilead Sciences Inc.'s (GILD) Remdesivir in hospitalized COVID-19 patients was paused due to a potential safety concern.
Launched in August, the phase III study, dubbed ACTIV-3, was initially designed to enroll about 300 volunteers who have been hospitalized with mild to moderate COVID-19. The study is led by the National Institutes of Health.
Lilly said Monday that there was insufficient evidence that LY-CoV555 improved clinical outcomes when added to other treatments in hospitalized patients with COVID-19. But, the company remains confident based on data from BLAZE-1 study that LY-CoV555 monotherapy may prevent progression of disease for those earlier in the course of COVID-19.
Meanwhile, Eli Lilly said it will continue other trials for LY-CoV555, including ACTIV-2, the NIH-sponsored study in recently diagnosed mild to moderate COVID-19 patients; BLAZE-1, Lilly's ongoing Phase 2 trial in people recently diagnosed with COVID-19 in non-hospitalized setting, studying bamlanivimab as monotherapy and in combination with etesevimab; and BLAZE-2, Lilly's Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities.
Based on data from BLAZE-1, Lilly submitted a request for EUA for bamlanivimab for the treatment of recently diagnosed mild to moderate COVID-19 illness in high-risk patients to the U.S. FDA in early October.
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