Armata Pharmaceuticals, Inc. announced positive topline results from the completed Phase 1b/2a SWARM-P.a. trial evaluating AP-PA02, a novel, inhaled multi-phage therapeutic for the treatment of chronic pulmonary Pseudomonas aeruginosa infections in cystic fibrosis patients. The SWARM-P.a., trial was a multi-center, randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study that evaluated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AP-PA02. Data indicate that AP-PA02 was well-tolerated with a treatment emergent adverse event (TEAE) profile similar to placebo.

Only mild, self-limited adverse events possibly related to 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. Bacterial levels of P. aeruginosa in the sputum were measured at several timepoints and compared to baseline levels prior to study drug administration. Trends suggest improvement in bacterial load reduction for subjects treated with AP- PA02 at end of treatment as compared to placebo after ten days of dosing.

Importantly, for subjects with the average exposure of susceptible phage, there was durability of approximately two-log reduction from end of treatment to end of study (day 28 post dose). PK/PD analysis indicates significant microbiological impacts in the subjects with exposures. Armata also announced that it has dosed the first subject in its Tailwind study of nebulized AP-PA02 in patients with non-cystic fibrosis bronchiectasis (NCFB).

The Tailwind study (NCT05616221) is a double blind, randomized, placebo- controlled trial that will evaluate the safety, tolerability, and efficacy of inhaled AP-PA02 as monotherapy, as well as in combination with inhaled antibiotics. Pharmacokinetic data from SWARM-P.a. were used to design an optimized AP-PA02 dosing regimen for the Tailwind study. Insights from Tailwind will be important for the concurrent design of the Phase 2b cystic fibrosis study, which will be powered to evaluate the efficacy and durability of phage response over time.