Armata Pharmaceuticals(US:ARMP) Prnewswire·2026-01-13 12:00Core Viewpoint - Armata Pharmaceuticals has received FDA approval to advance its bacteriophage product candidate AP-SA02 to Phase 3 clinical trials for treating complicated Staphylococcus aureus bacteremia, marking a significant milestone in bacteriophage therapy development [1][2][3] Group 1: FDA Approval and Study Advancement - The FDA confirmed that data from the Phase 2a diSArm study supports the advancement of AP-SA02 to Phase 3, providing guidance on key study design elements [2] - The Phase 3 study is expected to begin in the second half of 2026, focusing on the superiority of AP-SA02 over current standard treatments [1][2] - Armata is addressing FDA comments related to Chemistry, Manufacturing, and Controls (CMC) and is preparing for a future Biologics License Application [2] Group 2: Study Details and Significance - The Phase 2a diSArm study was a randomized controlled trial that demonstrated the efficacy of phage therapy, representing a significant achievement for Armata [3][6] - The primary endpoint for the Phase 3 study will be clinical response at the end of best available antibiotic therapy and 28 days later [4] - The diSArm study was partially funded by a $26.2 million Department of Defense award, highlighting the support for innovative treatment options [7][8] Group 3: Company Overview and Commitment - Armata Pharmaceuticals focuses on developing high-purity, pathogen-specific bacteriophage therapeutics for antibiotic-resistant infections [9] - The company is advancing a pipeline of phage candidates targeting various pathogens, including Staphylococcus aureus [9] - Armata is committed to phage therapy development, utilizing in-house cGMP manufacturing to support commercialization efforts [9]