Company: ARMP
Filing Date: 2025-08-13
Form Type: S-3
Source: 0001104659-25-077648
Chunk: 8

Company: Armata Pharmaceuticals, Inc.
Filing Date: 2025-08-13
Form: S-3
Chunk 8
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 IND application for AP-PA02,
in a second indication, NCFB. On December 19, 2024, Armata announced encouraging results from the completed “Tailwind”
study – a Phase 2 multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy
of inhaled AP-PA02 in subjects with NCFB and chronic pulmonary P. aeruginosa infection. Data indicated that inhaled AP-PA02
provides a durable reduction of P. aeruginosa in the lung, with a favorable safety and tolerability profile. The Tailwind study
was conducted in two cohorts running in parallel: subjects in one cohort (cohort A) received inhaled AP-PA02 as monotherapy, while subjects
in another cohort (cohort B) received inhaled AP-PA02 in combination with inhaled anti-pseudomonal antibiotic treatment. Subjects in both
cohorts were dosed at home by nebulization with study drug administered every 12 hours for 10 days and were followed for approximately
four weeks after receiving their last dose of study drug. The primary efficacy endpoint was the reduction in P. aeruginosa colony
forming units (“CFUs”) in lung sputum at one week following completion of dosing (day 17) compared to baseline. Per the statistical
analysis plan, efficacy analysis of each independent cohort showed no significant difference between subjects treated with AP-PA02 and
placebo due to small numbers of subjects in each cohort. Notably, a post-hoc intent-to-treat analysis (n=33 active and n=15 placebo; all
subjects from both cohorts) demonstrated a statistically significant reduction of P. aeruginosa CFUs in the lung at day
17 (AP-PA02 vs. placebo; P=0.05). The reduction in P. aeruginosa CFUs persisted two weeks following completion of dosing
with AP-PA02 when compared with placebo at day 24 (AP-PA02 vs. placebo; P=0.015). Additionally, paired analysis of P. aeruginosa CFU
density at baseline compared to day 10 (P=0.03), day 11 (P=0.01), day 17 (P=0.003) and day 24 (P=0.018) was significant in the AP-PA02-treated
cohort. We believe the data suggest that AP-PA02 alone is as