Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AP-PA02 · 2 trials · 6 indications
Change from baseline in P. Aeruginosa density (colony forming units) as measured in induced sputum samples one week after end of treatment.
Incidence and severity of treatment emergent adverse events of single and multiple doses of AP-PA02 administered by inhalation
| 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...
AP-PA02 is an investigational inhaled therapy being studied for chronic Pseudomonas aeruginosa lung infections in patients with cystic fibrosis and non-cystic fibrosis bronchiectasis. It is administered via inhalation and is currently in clinical development, with completed Phase 1 and Phase 2 trials.
AP-PA02 is being developed by Armata Pharmaceuticals, Inc., a biopharmaceutical company. Armata's stock is traded under the ticker symbol ARMP. The company is focused on developing phage-based therapies for infectious diseases.
AP-PA02 has completed Phase 1 and Phase 2 clinical trials. The Phase 1 trial evaluated safety and tolerability in cystic fibrosis patients, and the Phase 2 trial studied safety, phage kinetics, and efficacy in non-cystic fibrosis bronchiectasis patients. It remains investigational and is not yet approved.
AP-PA02 has been studied in two completed trials. NCT04596319 was a Phase 1/2 trial in cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infections, enrolling 29 participants. NCT05616221 was a Phase 2 trial in non-cystic fibrosis bronchiectasis patients, enrolling 48 participants. Both were conducted in the United States.
AP-PA02 is classified as a monoclonal antibody modality, though it is designed for inhalation to treat chronic Pseudomonas aeruginosa lung infections. It is being developed for use in cystic fibrosis and non-cystic fibrosis bronchiectasis patients.