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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: 04 Mar 2026

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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

  • 23 Feb 2026 According to an Armata Pharmaceuticals media release, company announced that the U.S. Food and Drug Administration (the FDA) has granted AP-SA02, for intravenous use as a Qualified Infectious Disease Product (QIDP) for adjunct treatment of complicated bacteremia caused by methicillin-sensitive S. aureus (MSSA) or methicillin resistant S. aureus (MRSA).
  • 13 Jan 2026 According to an Armata Pharmaceuticals media release, company announced the conclusion of an End-of-Phase 2 (EOP2) written response from the U.S. Food and Drug Administration (FDA) and plans to advance the Company's intravenously-administered Staphylococcus aureus bacteriophage product candidate, AP-SA02, into a Phase 3 clinical study in complicated S. aureus bacteremia.
  • 12 Nov 2025 According to an Armata Pharmaceuticals media release, abstract was accepted as a late-breaking abstract for oral presentation and was presented by Dr. Loren G. Miller, M.D., M.P.H., Professor of Medicine, David Geffen School of Medicine at UCLA, Chief, Division of Infectious Diseases at Harbor-UCLA Medical Center and the Lundquist Institute.

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