Armata Pharmaceuticals announced that it has received agreement from the FDA on an Agreed Initial Pediatric Study Plan ("Agreed iPSP"), which establishes the agreed regulatory framework for the future evaluation of AP-SA02 for the adjunct treatment of complicated Staphylococcus aureus bacteremia ("SAB") in pediatric patients. Agreement with the FDA on an iPSP is a regulatory requirement that must be met prior to submitting a Biologics License Application ("BLA").
"Reaching agreement with the FDA on our Agreed iPSP for AP-SA02 is an important regulatory milestone that reflects our commitment to addressing the needs of both adult and pediatric patients with complicated SAB," said Dr. Deborah Birx, Chief Executive Officer of Armata. "Pediatric patients, especially very young premature babies and newborns, represent a particularly vulnerable population with limited treatment options for serious S. aureus infections, and we are pleased to have an aligned, FDA-endorsed pediatric development framework in place. This agreement positions us to work towards efficiently expanding development beyond adults while continuing to advance AP-SA02 toward potential registration."
The Agreed iPSP outlines a proposed pediatric development program targeting patients up to 17 years of age with complicated SAB, the same indication that Armata is pursuing in adults. Consistent with FDA requirements under the Pediatric Research Equity Act (PREA) and with established FDA and European Medicines Agency regulatory frameworks, the FDA agreed that because the disease pathophysiology and treatment response in SAB are consistent across all age groups, pediatric studies should be deferred until safety and efficacy data are generated in adults in the planned Phase 3 program. Following completion of the adult Phase 3 study which is expected to initiate in the second half of 2026, the proposed program will comprise a single, multicenter, open-label, pediatric study to assess safety, tolerability, and clinical response outcomes. This strategy establishes a pathway for potential future expansion of AP-SA02 into the pediatric population while prioritizing patient safety and efficient clinical development.
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