Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06998043 | Study With Phage for CF Subjects With Pseudomonas Lung Infection | PHASE2 | RECRUITING | 63 | — | — | Jul 2, 2025 | Sep 1, 2026 | Jul 22, 2025 | 14 | United States |
Change from baseline in PsA colony-forming units (CFU) per g of sputum
| Arm | Type | Description |
|---|---|---|
| BX004 | EXPERIMENTAL | Participants will be randomized to receive standard dose of nebulized bacteriophage |
| Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive nebulized placebo |
| Name | Type | Description |
|---|---|---|
| BX004 | BIOLOGICAL | Bacteriophage |
| Placebo | OTHER | Placebo |
Key Inclusion Criteria: * Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care inhaled antibiotics (cycling or continuous regimen) or no inhaled antibiotics * Age ≥ 18 years * FEV1 40%-80% predicted * Clinically stable lung disease * Willing an...