The National Institutes of Health (NIH) is embarking on a groundbreaking clinical trial to assess the safety and effectiveness of an experimental monoclonal antibody aimed at combating enterovirus D68 (EV-D68), a virus linked to severe respiratory and neurological conditions such as acute flaccid myelitis (AFM), akin to polio.
EV-D68 has been a growing concern in public health due to its association with periodic outbreaks of AFM, notably observed in the United States every other year during late summer months over the past decade. Despite these recurrent outbreaks, there are currently no approved treatments specifically targeting severe EV-D68 infections or AFM. Treatment options are limited to supportive care and therapies for associated immune disorders, which have not undergone comprehensive evaluation.
The NIH-sponsored phase 1 clinical trial is led by principal investigator C. Buddy Creech, M.D., M.P.H., from Vanderbilt University Medical Center, in collaboration with academic centers across the US through the NIAID-funded Infectious Diseases Clinical Research Consortium. The trial aims to evaluate the safety profile, duration in the body, and optimal dosage of an investigational monoclonal antibody known as EV68-228-N.
Developed from a neutralizing antibody isolated at Vanderbilt University Medical Center, EV68-228-N has shown promising results in laboratory models by effectively neutralizing various clinical strains of EV-D68 from multiple epidemic years. Manufactured using a plant-based protein development platform by Kbio, Inc., the antibody will be administered intravenously to 36 healthy volunteers aged 18 to 49. This includes a placebo group and three groups receiving different doses of EV68-228-N.
Monitoring will be rigorous, with initial participants observed for at least 72 hours post-treatment before subsequent dosing. Follow-up will involve nine in-person evaluations over the next 120 days to assess safety and efficacy.
EV-D68, first identified in 1962, usually causes mild respiratory symptoms but has been increasingly associated with severe illnesses like AFM. Its prevalence has prompted heightened CDC surveillance since a notable outbreak in 2014, which led to 120 cases of AFM across 34 states. Subsequent years have seen continued detection, particularly during late summer and fall, with notable spikes in 2016 and 2018.
The NIH’s NIAID, dedicated to advancing research on infectious and immune-mediated diseases, underscores the urgency and importance of developing targeted therapies for conditions like EV-D68 and AFM. As part of the US Department of Health and Human Services, NIH remains at the forefront of medical research, striving to improve prevention, diagnosis, and treatment options for a wide spectrum of diseases, both common and rare.