Press release
Thursday June 27, 2024
Monoclonal antibody developed from the blood of convalescent patients.
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 serious respiratory and neurological diseases such as acute flaccid myelitis (AFM) – similar to polio. Scientists are working to better understand AFM, which has emerged in the United States with spikes in cases every two years, primarily in late summer for the past 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 intermittent outbreaks of AFM.
There are no Food and Drug Administration-approved treatments for severe EV-D68 or AFM infection. Standard care is limited to supportive therapy and treatment of immune disorders, which have 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 in 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 neutralized several EV-D68 clinical strains over several epidemic years. Kbio, Inc. uses its plant protein development platform to manufacture EV68-228-N.
Led by Principal Investigator C. Buddy Creech, MD, MPH, at Vanderbilt University Medical Center, the NIH National Institute of Allergy and Infectious Diseases (NIAID)-sponsored Phase 1 study will evaluate the safety of EV68-228-N, how long it lasts in the body, and the most effective dose. The trial will also enroll participants from the University of Maryland, College Park, and will be led by E. Adrianne Hammershaimb, MD. The study is being conducted in collaboration with academic medical centers across the United States through the NIAID-funded Infectious Diseases Clinical Research Consortium, which includes the NIAID-funded Vaccine and Therapeutics Evaluation Units.
The NCT06444048 clinical trial will recruit 36 healthy volunteers aged 18 to 49 years. Six will receive a placebo (control group) and 30, divided into groups of 10, will receive a dose of 3, 10 or 30 mg/kg of EV68-228-N intravenously. . As part of the safety evaluation, scientists will monitor the first two study participants in each group receiving the experimental treatment for at least 72 hours before the others receive the infusion. Researchers will then monitor and evaluate study participants in nine subsequent in-person exams over the next 120 days.
According to the CDC, EV-D68 was first identified in California in 1962 and is one of more than 100 non-polio enteroviruses. EV-D68 usually causes mild respiratory illnesses. Non-polio enteroviruses are very common. Most infections are asymptomatic or cause mostly mild symptoms, such as runny nose, sneezing, coughing, rashes, mouth sores, aches, and muscle pain. Serious symptoms may include wheezing and difficulty breathing.
Beginning in 1987, physicians and public health officials began reporting sporadic cases of EV-D68 to the CDC. However, between August and December 2014, EV-D68 caused an outbreak of respiratory illness in the United States and 120 cases of AFM in 34 states. This raised awareness of EV-D68-associated illnesses, and beginning in 2014, CDC surveillance for EV-D68 expanded. EV-D68 and AFM cases were subsequently detected annually in the United States, primarily in late summer and early fall, with pronounced peaks in 2016 and 2018.
NIAID conducts and supports research – at the NIH, across the United States and around the world – to study the causes of infectious and immune-mediated diseases and to develop better ways to prevent, diagnose and treat these diseases. NIAID-related press releases, fact sheets, and other materials are available on the NIAID website.
About the National Institutes of Health (NIH):NIH, the nation’s medical research agency, comprises 27 institutes and centers and is part of the U.S. Department of Health and Human Services. NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, studying the causes, treatments, and cures for common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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