Eli Lilly COVID-19 antibody therapy trial paused over safety concerns

pharmafile | October 14, 2020 | News story | Research and Development COVID, Eli Lilly, coronavirus 

Eli Lilly has stopped enrolling volunteers in clinical trials of its antibody treatment for the novel coronavirus over safety concerns. 

The trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), has so far enrolled 326 patients. Neither it, or the company, have announced what the safety issue is. 

The design of the trial calls for the data and safety monitoring board on the study to examine the results of the first 300 participants, including their health needs due to coronavirus, before enrolling more patients. 

The NIAID board is now considering whether to enroll a further 700 participants and will review the data at a meeting on 26 October, 

An NIAID spokesperson said the enrollment is paused due to an “abundance of caution” and the board is “continuing data collection and follow-up of current participants for safety and efficacy.”

This study is investigating whether the antibody treatment (bamlanivimab) could help hospitalised coronavirus patients recover and uses a monoclonal antibody that mimics the antibodies the body makes naturally in response to contracting the virus. It is similar to the Regeneron treatment President Trump received while fighting COVID-19. 

This delay follows Eli Lilly requesting an Emergency Use Authorization from the FDA for the treatment last week, after early trials showed the therapy was well tolerated with little drug-related side-effects. 

Conor Kavanagh

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