097-20 | A Study to Evaluate EDP 938 Regimens in Children With Respiratory Syncytial Virus (RSV)

Overview

“A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 2-Part Study to Evaluate EDP-938 Regimens in Subjects aged 28 Days to 24 Months Infected with Respiratory Syncytial Virus (RSV)”

Respiratory syncytial virus (RSV) is a virus that infects the lungs and represents a serious unmet medical need in infants and children, as well as immune-compromised individuals and the elderly. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under 1 year of age in the United States. Each year, 57,000 to 125,000 children in this group are hospitalized due to RSV infection. Also, at increased risk of a severe RSV infection, are children with compromised (weakened) immune systems due to a medical condition or medical treatment, adults with compromised immune systems and those 65 and older. There is currently no safe and effective therapy for already established RSV infection.EDP-938, Enanta’s lead N-protein inhibitor, is being developed for the treatment of RSV infection. Enanta believes EDP-938 is differentiated from fusion inhibitors currently in development by others for RSV because this N-protein inhibitor targets the virus’ replication machinery and has demonstrated high barriers to resistance against the virus in vitro. EDP-938 has also been shown to reduce viral load below the level of detection in vivo. Additionally, it is possible that N-protein inhibitors may be effective treatments at later stages of infection.