Enanta Pharmaceuticals Announces Positive Data From a Phase 1 Clinical Study of EDP-323, an Oral, L-Protein Inhibitor in Development for the Treatment of Respiratory Syncytial Virus - Seite 2

A total of 82 subjects (n=50 in SAD; n=32 in MAD) received at least one dose of EDP-323 or placebo. Overall, EDP-323 was generally safe and well-tolerated in healthy subjects up to 800 mg for up to seven days. Among participants receiving EDP-323, most adverse events (AEs) were mild, and there were no serious or severe AEs. There was one study discontinuation due to syncope, in the SAD/FE group, which was deemed unlikely to be related to EDP-323. In the MAD phase, three AEs deemed possibly related to EDP-323 were mild, with two headaches and one gastrointestinal event. There were no discontinuations due to AEs in the MAD phase.

EDP-323 exposure increased with increasing single and multiple dosing up to 600 mg with a half-life ranging from 11-17 hours, supporting once daily dosing. No food effect was observed with a high fat meal during the 200 mg SAD FE cohort, suggesting that EDP-323 can be administered without regard to food.

EDP-323 doses ranging from 200 to 800 mg once-daily resulted in strong EC₉₀ multiples against both RSV A and B strains. Specifically, EDP-323 administered once daily for seven days resulted in C₂₄ (C_trough) concentrations at steady state of 11- to 44-fold over the protein adjusted EC₉₀ (0.3 nM) against both RSV A and B strains.

Based on these positive data, Enanta plans to initiate a human challenge study evaluating EDP-323 by early fourth quarter of 2023.

About Respiratory Syncytial Virus
RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under one year of age in the United States and a significant cause of respiratory illness in older adults and immunocompromised individuals.¹ According to the Centers for Disease Control and Prevention, virtually all children in the United States get an RSV infection by the time they are two years old and one to two out of every 100 children younger than six months of age with an RSV infection may need to be hospitalized.² Globally, there are an estimated 33 million cases of RSV annually in children less than five years of age, with about 3 million hospitalized and up to approximately 120,000 dying each year from complications associated with the infection.³ RSV represents a significant health threat for adults older than 65 years of age, with an estimated 177,000 hospitalizations and 14,000 deaths associated with RSV infections annually in the United States.⁴