Trial to test monoclonal antibody for virus of growing concern


The National Institutes of Health (NIH) is sponsoring a clinical trial to evaluate the safety of an investigational monoclonal antibody to treat enterovirus D68 (EV-D68), which can cause severe respiratory and neurological diseases such as acute flaccid myelitis (AFM).

AFM has emerged in the United States with spikes in cases every other year, primarily in the late-summer months over the last decade.

The US Centers for Disease Control and Prevention (CDC) identified increases in AFM cases in 2014, 2016, and 2018. EV-D68 is a virus of growing public health concern due to its association with the intermittent AFM outbreaks.

Standard care for severe EV-D68 infection or AFM is limited to supportive treatment and treatment for immune disorders, which has not been comprehensively evaluated.

Between 2017 and 2019, scientists at Vanderbilt University Medical Center, Nashville, Tennessee, identified and isolated a neutralising antibody, called EV68-228, from patients recovering from EV-D68 infection.

Then, with collaborators from Utah State University, KBio, and ZabBio, the scientists developed an experimental antibody, called EV68-228-N, for testing.

In laboratory models, the monoclonal antibody potently neutralised multiple clinical EV-D68 strains across multiple epidemic years.

The Phase I study sponsored by NIH’s National Institute of Allergy and Infectious Diseases (NIAID) will evaluate the safety of EV68-228-N, how long it lasts in the body, and the most effective dose.

Image shows: A 3D rendering of enterovirus D68 (viral proteins red, yellow, blue) with human monoclonal antibody EV68-228 (orange/purple). To the right in the background is a colorised transmission electron micrograph of enterovirus D68 virus particles (green). 3D rendering by NIAID; micrograph, repositioned and recoloured by NIAID, courtesy of CDC. Credit: NIAID and CDC.

Diana Spencer, Senior Digital Content Editor, DDW

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