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Lilly, NIH Halt Covid-19 Antibody Therapy Trial

Stop signs graphic

(kropekk_pl, Pixabay)

27 Oct. 2020. Drug maker Eli Lilly and National Institutes of Health are stopping a clinical trial testing a synthetic antibody to treat hospitalized Covid-19 patients. The trial sponsors say results so far show little clinical value to hospitalized patients from the Lilly synthetic monoclonal antibody therapy bamlanivimab, previously code-named LY-CoV555.

Eli Lilly and Co. in Indianapolis says in a company statement the decision to stop the trial of hospitalized patients does not apply to its other clinical studies of bamlanivimab testing the synthetic antibody among Covid-19 patients: those recently diagnosed with mild to moderate symptoms, non-hospitalized patients, residents and staff in long-term care facilities, and in combination with other drugs.

Bamlanivimab was initially developed by biotechnology company AbCellera Biologics in Vancouver, British Columbia as an immunoglobulin G antibody designed to block the SARS-CoV-2 spike protein that penetrates and infects cells. AbCellera says it screened more than 5 million immune-system cells against a blood sample from one of the first people in the U.S. infected with the novel coronavirus, as it was called at the time.

From this screening, AbCellera says it identified some 500 unique human antibody sequences that respond to the SARS-CoV-2 virus responsible for Covid-19 infections. Lilly and AbCellera partnered with the Vaccine Research Center at National Institute of of Allergy and Infectious Diseases, or NIAID, part of National Institutes of Health, to identify the best-performing candidates.

NIAID is also the co-sponsor with Lilly of the now-halted clinical trial. The study is part of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines, or ACTIV, initiative, a partnership with pharma and biotechnology companies, and other federal agencies, to coordinate and speed Covid-19 therapies and vaccines. The ACTIV-3 trial, in this case, is enrolling 10,000 participants at 51 hospital sites testing bamlanivimab with the antiviral drug remdesivir against a placebo.

The trial uses an adaptive design with a master protocol that allows trial sponsors to add or remove new drugs for testing, as well as adjust the populations tested in the trial as data are collected. The study team planned to first enroll 300 hospitalized Covid-19 patients, then after five days assess any changes in their clinical status using a standard ordinal scale. If the test agent, bamlanivimab in this case, was shown safe and effective, more participants would be recruited. Participants would be monitored for another 90 days, after their release from the hospital.

NIAID says an independent data and safety monitoring board reviewed the ACTIV-3 data after enrolling 326 participants, and recommended that the study enroll no more participants. However, all those enrolled will continue to be monitored for 90 days, as planned.

Earlier in October, that same data and safety monitoring board paused the ACTIV-3 trial when a safety issue emerged, described by NIAID in an institute statement as “a pre-defined boundary for safety was reached at day 5.” NIAID notes, however, “differences in safety outcomes between the groups were not significant in the updated data set and the Oct. 26 decision was driven by lack of clinical benefit for LY-CoV555 in a hospitalized population.”

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