Armata Pharma’s inhaled AP-PA02 shows positive results in Phase 2 study

Armata Pharmaceuticals (ARMP) announced “encouraging” topline results from its Phase 2 trial evaluating AP-PA02, a novel, inhaled multi-phage therapeutic for the treatment of chronic pulmonary Pseudomonas aeruginosa – P.a. or P. aeruginosa – infections in non-cystic fibrosis bronchiectasis, or NCFB, patients. The study evaluated the safety, pharmacokinetics and efficacy of inhaled AP-PA02. The primary efficacy endpoint was the reduction in P.a. colony forming units, or CFUs, in the lung sputum at one week following completion of dosing compared to baseline. 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. A post-hoc intent-to-treat analysis demonstrated a statistically significant reduction of P.a. CFUs in the lung at day 17 which persisted two weeks following completion of dosing with AP-PA02 vs. placebo at day 24. Additionally, paired analysis of P.a. CFU density at baseline was significant in the AP-PA02-treated cohort. Armata believes the data suggest that AP-PA02 alone is as effective as the combination therapy of phage and antibiotics in reducing P.a. CFUs in the lung. The study data indicate the potential for phage therapy to reduce reliance on chronic antibiotic use. Safety data indicate that inhaled AP-PA02 was well-tolerated with treatment-emergent adverse events mild and self-limiting.