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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05616221 | Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection | PHASE2 | COMPLETED | 48 | — | — | Jan 10, 2023 | Aug 8, 2024 | Jan 5, 2026 | 23 | United States |
Change from baseline in P. Aeruginosa density (colony forming units) as measured in induced sputum samples one week after end of treatment.
| Arm | Type | Description |
|---|---|---|
| AP-PA02 | EXPERIMENTAL | Anti-pseudomonal bacteriophage |
| Placebo | PLACEBO_COMPARATOR | Inactive isotonic solution |
| Name | Type | Description |
|---|---|---|
| AP-PA02 | BIOLOGICAL | Bacteriophage administered via inhalation |
| Placebo | OTHER | Inactive Placebo administered via inhalation |
Key Inclusion Criteria: * ≥ 18 years old * Body mass index (BMI) of ≥ 18 kg/m2 * Evidence of bronchiectasis per CT * Evidence of chronic pulmonary Pseudomonas aeruginosa infection * Willing to undergo sputum induction procedures at designated study visits, and willing to provide expectorated sputum...