Study of Epetraborole in Patients With Treatment-refractory MAC Lung Disease
Summary
This is a pivotal Phase 2/3, double-blind, placebo-controlled study of epetraborole + OBR (Optimized Background Regimen) versus placebo + OBR in patients with treatment-refractory MAC lung disease. This study will enroll adult patients with treatment-refractory MAC lung disease who meet all eligibility criteria (including clinical, radiographic, and microbiological criteria).
Timeline
- Start
- 2022-05-20
- Primary completion
- 2024-12-18
- Completion
- 2024-12-18
Outcome
Missed primary endpoint
Stopped: “EBO-301 truncated Phase 3 study (n=97) misses primary endpoint; results unable to confirm clinical efficacy observed in Phase 2 study.”
registry analysis (superiority test); Epetraborole + OBR vs Placebo + OBR; p = 0.1863; Risk Difference (RD) 13.9 (95% CI -6.8 to 33.8) NCT05327803 ↗
registry analysis (superiority test); Epetraborole + OBR vs Placebo + OBR; p = 0.9822; Risk Difference (RD) -0.2 (95% CI -20.8 to 18.6) NCT05327803 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epetraborole | Small molecule | 500 mg | Oral |