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Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Safety, Tolerability, and Efficacy of Intravenous AP-SA02 As an Adjunct to Best Available Antibiotic Therapy for the Treatment of Adults with Bacteremia Due to Staphylococcus Aureus

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Trial Profile

Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Safety, Tolerability, and Efficacy of Intravenous AP-SA02 As an Adjunct to Best Available Antibiotic Therapy for the Treatment of Adults with Bacteremia Due to Staphylococcus Aureus

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 01 Apr 2025

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At a glance

  • Drugs AP-SA02 (Primary) ; Antibacterials
  • Indications Bacteraemia; Staphylococcal infections
  • Focus Adverse reactions; First in man
  • Acronyms diSArm Study
  • Sponsors Armata Pharmaceuticals

    • Most Recent Events

    • 26 Mar 2025 Status changed from active, no longer recruiting to completed.
    • 20 Mar 2025 According to an Armata Pharmaceuticals media release, Company anticipates topline data from the diSArm study in the first half of 2025. and Anticipate that findings from the diSArm study will inform the design of a pivotal trial strategy to be discussed with the U.S. Food and Drug Administration (the "FDA") that may enable Armata to obtain agreement on a path to potential approval.
    • 12 Nov 2024 According to an Armata Pharmaceuticals media release, Company anticipates topline data from the diSArm study in the first quarter of 2025. Topline results are also expected to inform the optimal dose of AP-SA02 to be evaluated in the larger definitive efficacy study.

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