The National Institutes of Health (NIH) has initiated a clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) to assess the safety and efficacy of an investigational monoclonal antibody designed to treat enterovirus D68 (EV-D68), a virus associated with severe respiratory and neurological diseases such as acute flaccid myelitis (AFM).

On the left is 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 colorized transmission electron micrograph of enterovirus D68 virus particles (green). 3D rendering by NIAID; micrograph, repositioned and recolored by NIAID, courtesy of CDC. Image Source:NIH. Gov

Highlights

The trial aims to evaluate the safety of EV68-228-N, a monoclonal antibody derived from the blood of recovering patients, which has shown promising results in neutralizing multiple clinical strains of EV-D68. Led by principal investigators C. Buddy Creech, M.D., M.P.H., and E. Adrianne Hammershaimb, M.D., the study will enroll 36 healthy volunteers to determine the antibody's safety profile, duration in the body, and optimal dosage.

Research and Development

Scientists at Vanderbilt University Medical Center, in collaboration with Utah State University, KBio, Inc., and ZabBio, developed EV68-228-N using a plant-based protein development platform. The antibody, initially identified as EV68-228, was isolated from patients recovering from EV-D68 infections between 2017 and 2019.

Clinical Trial Details

The Phase 1 clinical trial (NCT06444048) will involve administering EV68-228-N intravenously to participants, with 6 receiving a placebo and 30 receiving varying doses of the antibody. Safety will be monitored closely, with initial participants observed for 72 hours post-treatment and subsequent evaluations conducted over 120 days.

Background on EV-D68

EV-D68, first identified in 1962, is among over 100 non-polio enteroviruses. While often causing mild respiratory illnesses, it has been linked to sporadic outbreaks of severe illness, including AFM, with notable spikes in cases reported in the United States in 2014, 2016, and 2018.

Data Source: https://www.nih.gov/news-events/news-releases/nih-sponsored-trial-enterovirus-d68-therapeutic-begins