Armata Pharmaceuticals, Inc. (NYSE American: ARMP), a late clinical-stage biotechnology company developing bacteriophage therapeutics for antibiotic-resistant bacterial infections, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for AP-SA02. The intravenously administered multi-phage product is being developed to treat complicated bacteremia caused by methicillin-sensitive or methicillin-resistant Staphylococcus aureus.

The designation recognizes the urgent medical need for new treatments for S. aureus bacteremia, where current outcomes remain poor. AP-SA02 now holds Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product (QIDP) designations.

The designation is based on results from the Phase 1b/2a diSArm study. When added to best available antibiotic therapy, AP-SA02 demonstrated higher clinical cure rates than placebo. At day 28 post-treatment, 100% of AP-SA02 patients maintained clinical response without relapse, compared with 75% of patients receiving placebo. No serious adverse events were attributed to AP-SA02 in the study.

The drug product formulation enables intravenous dosing every six hours for five days. Patients also demonstrated favorable trends in disease resolution markers, including more rapid normalisation of C-reactive protein and Interleukin-10, biomarkers associated with mortality risk.

Dr. Deborah Birx, Chief Executive Officer of Armata, said:

“AP-SA02 has potential to represent an important advancement in treating complicated SAB and may become the first antibacterial therapy approved based on superiority to current standard-of-care treatment in this patient population.”

About AP-SA02

AP-SA02 is a fixed multi-phage cocktail being developed as an adjunct treatment for complicated Staphylococcus aureus bacteremia caused by methicillin-sensitive or methicillin-resistant strains. Its Phase 1b/2a clinical development received partial support from a $28.7 million Department of War award through the Medical Technology Enterprise Consortium. Armata plans to initiate a Phase 3 trial in the second half of 2026.

About Armata Pharmaceuticals, Inc.

Armata is a late clinical-stage biotechnology company developing high-purity, pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections. The company maintains in-house cGMP manufacturing and is developing candidates targeting Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens.