Armata Pharmaceuticals(US:ARMP) Prnewswireยท2025-05-19 11:00Core Insights - Armata Pharmaceuticals announced positive topline results from its Phase 1b/2a diSArm trial for AP-SA02, a novel bacteriophage therapeutic for Staphylococcus aureus bacteremia, demonstrating significant clinical improvements over best available antibiotic therapy [1][2][3] Group 1: Trial Overview - The diSArm study was a multicenter, randomized, double-blind, placebo-controlled trial assessing the safety, tolerability, and efficacy of intravenous AP-SA02 in addition to best available antibiotic therapy [3] - The intent-to-treat population included 50 subjects who received at least one dose of AP-SA02 or placebo [3] Group 2: Efficacy Results - A statistically significant increase in the responder rate was observed at the Test of Cure (TOC) for AP-SA02 treated subjects (88%) compared to placebo (58%) with a p-value of 0.047 [6] - At TOC for best available therapy (BAT) and at the end of study (EOS), 100% of AP-SA02 treated subjects clinically responded, while only 25% of placebo subjects were considered responsive [6] - All subjects infected with methicillin-resistant S. aureus (MRSA) treated with AP-SA02 cleared their infection by TOC for BAT with no evidence of relapse [6] Group 3: Safety Profile - AP-SA02 was well-tolerated with no treatment-related serious adverse events reported during the trial [1][4] - Two subjects experienced adverse events possibly related to the study drug, which were manageable [4] Group 4: Manufacturing and Future Plans - Armata has developed the capacity to manufacture over 10,000 full courses of phage therapy annually at its cGMP facility in California [9] - The company aims to move rapidly towards initiating a pivotal trial based on the favorable safety and efficacy results of AP-SA02 [9]