ARMP News & Events

Armata Pharmaceuticals announced that the U.S. FDA has granted AP-SA02, the company's Staphylococcus aureus multi-phage product candidate, for intravenous use as a Qualified Infectious Disease Product for adjunct treatment of complicated bacteremia caused by methicillin-sensitive S. aureus or methicillin resistant S. aureus. The company plans to advance AP-SA02 into a Phase 3 superiority study in complicated S. aureus bacteremia, anticipated to initiate in the second half of 2026.

Armata Pharmaceuticals announced the conclusion of an End-of-Phase 2 written response from the U.S. 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. The Phase 3 study is anticipated to initiate in the second half of 2026. FDA's Center for Biologics Evaluation and Research division, upon reviewing Armata's detailed EOP2 background package, confirmed that the safety and efficacy data from Armata's Phase 2a diSArm study support advancement to Phase 3. The FDA provided critical guidance on key elements of the Phase 3 study design, which will assess the superiority of AP-SA02 over the current standard of care for the treatment of complicated S. aureus bacteremia. Armata is addressing FDA comments, including on Chemistry, Manufacturing, and Controls and aligning them with the Company's existing Phase 3 manufacturing and quality strategy. The FDA also included recommendations for the future Biologics License Application and is amenable to Armata submitting a request for Qualified Infectious Disease Product Designation for AP-SA02. The company is already addressing many of the clinical and CMC comments from FDA and has submitted the request for QIDP.