AP-SA02 - (diSARM)

Sept. 14, 2026: Armata Pharmaceuticals, Inc. (NYSE: ARMP) said the FDA granted Breakthrough Therapy designation to AP-SA02, an intravenously administered multi-phage candidate for adjunct treatment of complicated Staphylococcus aureus bacteremia caused by MSSA or MRSA. The designation was supported by Phase 1b/2a diSArm data in adults with complicated SAB.

In diSArm, AP-SA02 was given every six hours for five days on top of best available antibiotic therapy versus placebo plus antibiotics. The regimen was reported as well tolerated, with no serious adverse events attributed to AP-SA02. At end of study, 28 days after completion of antibiotic therapy, 100% of AP-SA02-treated patients maintained clinical response without relapse versus 75% with placebo. The company also reported higher and earlier clinical cure rates and favorable trends in faster normalization of CRP and IL-10.

AP-SA02 now holds Breakthrough Therapy, Fast Track, and QIDP designations. Positive Phase 2a results were presented in a late-breaking oral presentation at IDWeek 2025 in October 2025. Armata said it plans to start a Phase 3 superiority study in complicated SAB in the second half of 2026.