A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model
Summary
A randomized, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-323 in healthy subjects infected with RSV-A Memphis 37b. This study is designed to assess the antiviral effect of EDP-323 compared to a placebo control in the respiratory syncytial virus challenge model.
Timeline
- Start
- 2023-11-20
- Primary completion
- 2024-06-17
- Completion
- 2024-07-12
Outcome
Met primary endpoint
registry analysis (superiority test); EDP-323 High Dose vs Placebo; p <0.0001; Difference in least square (LS) means -540.56 (95% CI -680.80 to -400.33); ANCOVA NCT06170242 ↗
release “Treatment With Once-Daily EDP-323 Met Primary and Secondary Endpoints” enanta.com ↗
release “In a human challenge study, EDP-323 achieved highly statistically significant reductions in both viral load and clinical symptoms compared to placebo.” enanta.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EDP-323 | Unknown | — | Oral |