Late clinical-stage biotechnology company Armata Pharmaceuticals Inc (NYSE American:ARMP) announced on Monday that the US Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation to AP-SA02, the company's Staphylococcus aureus (S. aureus) multi-phage product candidate, for intravenous use for adjunct treatment of complicated bacteraemia caused by methicillin-sensitive S. aureus (MSSA) or methicillin resistant S. aureus (MRSA).

Armata is developing AP-SA02, a fixed multi-phage phage cocktail, for the treatment of complicated bacteraemia caused by S. aureus, including MSSA and MRSA strains.

The company plans to advance AP-SA02 into a Phase 3 superiority study in complicated S. aureus bacteraemia, anticipated to initiate in the second half of 2026.

Dr. Deborah Birx, Armata CEO, said: "The FDA's decision to grant QIDP designation to AP-SA02 underscores the urgent need for innovative antibacterial therapies to address serious and drug-resistant S. aureus infections. This designation recognises the potential of AP-SA02 and supports our mission to advance bacteriophage-based therapies to patients with unmet medical needs through efficient, rigorously designed, randomised controlled clinical trials."