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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

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: 07 Apr 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

  • 19 Mar 2026 According to an Armata Pharmaceuticals media release,The FDA confirmed that the safety and efficacy data from Armatas Phase 2a diSArm study are sufficient to start a Phase 3 trial.
  • 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.

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