Biotechnology company Armata Pharmaceuticals Inc (NYSE American: ARMP) reported on Monday that it has received U.S. Food and Drug Administration Breakthrough Therapy designation for AP-SA02, its intravenous multi-phage product candidate for adjunct treatment of complicated Staphylococcus aureus bacteremia caused by MSSA or MRSA.

The designation is supported by Phase 1b/2a diSArm study data showing AP-SA02 plus best available antibiotic therapy was well tolerated and produced higher and earlier clinical cure rates than placebo plus antibiotics. At 28 days after completion of antibiotic treatment, 100% of AP-SA02-treated patients maintained a clinical response without relapse, compared with 75% for placebo.

AP-SA02 already holds FDA Fast Track and Qualified Infectious Disease Product designations. Armata plans to advance the candidate into a Phase 3 superiority study in complicated bacteremia, expected to begin in the second half of 2026.