Armata Pharmaceuticals, Inc. (NYSE American:ARMP) on October 22, 2025, announced positive results from its recently completed Phase 2a diSArm study of AP-SA02 as a potential treatment for complicated Staphylococcus aureus bacteremia, presented at IDWeek 2025™.
The Phase 2a study, which enrolled and dosed 42 patients, demonstrated higher clinical response rates in the AP-SA02 group compared to placebo. At Day 12, clinical response rates were 88% (21/24) in the AP-SA02 group versus 58% (7/12) in the placebo group as assessed by blinded site investigators, and 83% (20/24) versus 58% (7/12) by the blinded Adjudication Committee. Critically, no patients in the AP-SA02 group experienced non-response or relapse at one week post-Best Available Antibiotic Therapy (BAT) or at the End of Study (four weeks post-BAT completion), compared to approximately 25% in the placebo group at both timepoints.
Dr. Loren G. Miller, M.D., M.P.H., stated that the results confirm, for the first time in a randomized clinical trial, the efficacy of intravenous phage therapy for *S. aureus* bacteremia, providing strong rationale for advancement into a Phase 3 superiority study. Dr. Deborah Birx, Chief Executive Officer of Armata, highlighted the positive results as a significant achievement, aiming to advance AP-SA02 into a pivotal trial. AP-SA02 was well-tolerated, with no serious adverse events related to the study drug. The company plans to initiate a pivotal Phase 3 trial in 2026, subject to review and feedback from the U.S. Food and Drug Administration.
