A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model
Summary
A randomised, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-938 in healthy subjects infected with RSV-A Memphis 37b. This study is designed to compare the antiviral effect of EDP-938 compared to a placebo control in the respiratory syncytial virus challenge model.
Timeline
- Start
- 2018-10-15
- Primary completion
- 2019-09-30
- Completion
- 2019-10-18
Outcome
Met primary endpoint
registry analysis (superiority test); Part 1: EDP-938 600 mg vs Part 1: Placebo; p < 0.001; LS Mean Difference -588.08 (95% CI -719.8 to -456.35); ANCOVA NCT03691623 ↗
release “A highly statistically significant reduction was observed for the primary efficacy endpoint, the area under the curve (AUC) for viral load” enanta.com ↗
release “The NEJM publication highlighted results from the Phase 2 human challenge study in which the primary efficacy endpoint was met” enanta.com ↗
Publications
- Levene RE, DeVincenzo J, Conery AL, Ahmad A, Or YS, Rhodin MHJ. EDP-938 Has a High Barrier to Resistance in Healthy Adults Experimentally Infected with Respiratory Syncytial Virus. J Infect Dis. 2025 Feb 20;231(2):e290-e298. doi: 10.1093/infdis/jiae471.
- Ahmad A, Eze K, Noulin N, Horvathova V, Murray B, Baillet M, Grey L, Mori J, Adda N. EDP-938, a Respiratory Syncytial Virus Inhibitor, in a Human Virus Challenge. N Engl J Med. 2022 Feb 17;386(7):655-666. doi: 10.1056/NEJMoa2108903.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | zelicapavir | Small molecule | 200 mg | Oral |
| Subject | zelicapavir | Small molecule | 300 mg | Oral |
| Subject | zelicapavir | Small molecule | 600 mg | Oral |