- Armata Pharmaceuticals Inc ARMP announced positive topline results from the completed Phase 1b/2a SWARM-P.a. trial evaluating AP-PA02 for chronic pulmonary Pseudomonas aeruginosa infections in cystic fibrosis patients.
- Data indicate that AP-PA02 was well-tolerated with a treatment-emergent adverse event (TEAE) profile similar to a placebo.
- Only mild, self-limited adverse events possibly related to the study drug were reported in a few subjects.
- PK findings confirm that AP-PA02 can be effectively delivered to the lungs through nebulization with minimal systemic exposure.
- Single ascending doses (SAD) and multiple ascending doses (MAD) resulted in a proportional increase in exposure as measured in induced sputum.
- Additionally, achieved exposures were relatively consistent from subject to subject.
- Trends suggest improvement in bacterial load reduction for subjects treated with AP-PA02 at the end of treatment compared to placebo after ten days of dosing.
- Importantly, for subjects with the highest average exposure of susceptible phage, there was the durability of approximately two-log reduction from the end of treatment to the end of the study (day 28 post-dose).
- PK/PD analysis indicates significant microbiological impacts in the subjects with the highest exposures.
- Armata has dosed the first subject in its Tailwind study of nebulized AP-PA02 in patients with non-cystic fibrosis bronchiectasis.
- Price Action: ARMP shares are up 27.60% at $3.19 on the last check Monday.
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ARMPArmata Pharmaceuticals Inc
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