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Eli Lilly Ends Late-stage Covid-19 Antibody Trial In U.S. Due To Insufficient Data

(RTTNews) - 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.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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