Armata Pharmaceuticals, Inc. (NYSE American: ARMP) announced it has received agreement from the U.S. Food and Drug Administration on an Agreed Initial Pediatric Study Plan for AP-SA02, its bacteriophage therapeutic candidate for the adjunct treatment of complicated Staphylococcus aureus bacteremia.

The agreement establishes a regulatory framework for evaluating AP-SA02 in pediatric patients up to 17 years of age. Under the Pediatric Research Equity Act, the FDA agreed that pediatric studies should be deferred until adult safety and efficacy data are generated, given that disease pathophysiology and treatment response in S. aureus bacteremia are consistent across age groups.

Following completion of the adult Phase 3 study, which Armata expects to initiate in the second half of 2026, the proposed pediatric program will consist of a single, multicenter, open-label study to assess safety, tolerability, and clinical response outcomes.

Agreement on an Initial Pediatric Study Plan is a regulatory requirement that must be fulfilled before submitting a Biologics License Application to the FDA.

"Pediatric patients, especially very young premature babies and newborns, represent a particularly vulnerable population with limited treatment options for serious S. aureus infections," said Dr. Deborah Birx, Chief Executive Officer of Armata.

AP-SA02 targets complicated S. aureus bacteremia caused by both methicillin-sensitive and methicillin-resistant strains. The drug candidate holds Qualified Infectious Disease Product and Fast Track designations from the FDA. Positive results from the Phase 2a diSArm study were presented at IDWeek 2025 in October 2025.