Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BX004 · 1 trial · 2 indications
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...