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) – similar to polio. Scientists are striving to better understand AFM, which has emerged in the United States with spikes in cases every other year, primarily in the late-summer months over the last decade. The U.
S. 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.
There are no Food and Drug Administration-approved treatments for severe EV-D68 infection or AFM. Standard care is limited to supportive treatment and treatment for immune disorders, which has not been comprehensively evaluated. EV-D68 likely spreads from person to person when an infected person coughs, sneezes, or touches a surface that is then touched by others.
Between 2017 and 2019, scientists at Vanderbilt University Medical Center, Nashville, Tennessee, identified and isolated a neutralizing antibody, called EV68-228, from patients recovering from EV-D68 infection. Then, with collaborators from Utah State University, KBio, Inc., and ZabBio, the scientists developed an experimental antibody, called EV68-228-N, for testing.
In laboratory models, the monoclonal antibody potently ne.