Armata Pharmaceuticals Secures FDA Agreement on Initial Paediatric Study Plan for AP-SA02
Tuesday, July 14, 2026
Armata Pharmaceuticals has received agreement from the US Food and Drug Administration (FDA) on its Initial Paediatric Study Plan (iPSP) for AP-SA02, supporting the future evaluation of the investigational therapy as an adjunct treatment for complicated Staphylococcus aureus bacteraemia (SAB) in paediatric patients. The agreed iPSP establishes the regulatory framework for paediatric development and is a required step before submitting a Biologics License Application (BLA).
The agreement covers a proposed paediatric development programme for patients up to 17 years of age with complicated SAB, the same indication being studied in adults. In line with the FDA's Pediatric Research Equity Act (PREA) and existing regulatory guidance from both the FDA and the European Medicines Agency, paediatric studies will be deferred until safety and efficacy data are available from the planned Phase 3 adult trial.
Following completion of the adult Phase 3 study, which is expected to begin in the second half of 2026, Armata plans to conduct a single multicentre, open-label paediatric study. The trial will assess the safety, tolerability and clinical response of AP-SA02 in children with complicated SAB.
The company said the development strategy is designed to support future expansion of AP-SA02 into the paediatric population while maintaining patient safety and an efficient clinical development pathway.
AP-SA02 is a fixed multi-phage cocktail being developed as an adjunct treatment for complicated Staphylococcus aureus bacteraemia caused by either methicillin-sensitive S. aureus (MSSA) or methicillin-resistant S. aureus (MRSA). The therapy has received both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA.
The candidate was previously evaluated in the Phase 1b/2a diSArm trial, a multicentre, randomised, double-blind, placebo-controlled study that assessed intravenous AP-SA02 alongside the best available antibiotic therapy in adults with complicated SAB. Positive Phase 2a results were presented at IDWeek 2025, and Armata plans to advance the therapy into a Phase 3 superiority study in the second half of 2026.
Source: prnewswire.com
