Armata Pharmaceuticals Announces the Completion of Enrollment of its Phase 1b/2a diSArm Study Evaluating Intravenous AP-SA02 as a Potential Treatment for Staphylococcus aureus Bacteremia

Core Insights - Armata Pharmaceuticals has completed enrollment for its Phase 1b/2a diSArm study of intravenous AP-SA02, targeting Staphylococcus aureus bacteremia, with topline data expected in Q1 2025 [1][2] - The study aims to evaluate the safety and efficacy of AP-SA02 as a treatment option for patients suffering from serious bloodstream infections resistant to conventional antibiotics [2][3] Enrollment and Study Design - The diSArm study has enrolled 50 participants, marking a significant milestone in the development of AP-SA02 [1][2] - The study is designed as a randomized, double-blind, placebo-controlled trial, assessing the safety, tolerability, and efficacy of AP-SA02 in conjunction with best available antibiotic therapy [5] Clinical Safety and Efficacy - During the Phase 2a portion, Armata focused on the clinical safety of higher intravenous doses of AP-SA02, achieving dose escalation to 5E10 PFU every six hours without significant adverse events [2] - Two distinct subsets of subjects have shown evidence of phage persistence in the blood, indicating potential in vivo phage amplification [2] Future Plans and Regulatory Engagement - Armata plans to initiate a pivotal bacteremia efficacy study later in 2025, contingent on positive topline data [2][3] - The company intends to discuss the pivotal trial design with the U.S. Food and Drug Administration [3] Financial Support - The clinical development of AP-SA02 is partially funded by $21.6 million from the Defense Health Agency and Joint Warfighter Medical Research Program [4]