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 being developed by Armata Pharmaceuticals, Inc. (ARMP) and is currently in clinical development, with completed Phase 1 and Phase 2 trials.
AP-PA02 targets Pseudomonas aeruginosa, a bacterium that causes chronic lung infections in patients with cystic fibrosis and non-cystic fibrosis bronchiectasis. It is designed to be inhaled directly into the lungs to treat these infections.
AP-PA02 is being developed by Armata Pharmaceuticals, Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol ARMP. The company is focused on developing bacteriophage-based therapies for infectious diseases.
AP-PA02 is in clinical development. A Phase 1 trial in cystic fibrosis patients has been completed, and a Phase 2 trial in non-cystic fibrosis bronchiectasis patients has also been completed. It is not yet approved by the FDA and remains investigational.
AP-PA02 has been studied in two completed clinical trials. NCT04596319 was a Phase 1/2 study in cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infections, enrolling 29 participants. NCT05616221 was a Phase 2 study in non-cystic fibrosis bronchiectasis patients, enrolling 48 participants. Both trials were conducted in the United States.