Armata Pharma Reaches FDA Agreement on Pediatric Study Plan for AP-SA02
Armata Pharmaceuticals (ARMP) said Monday it has reached agreement with the US Food and Drug Administration on an agreed initial pediatric study plan for AP-SA02, clearing a regulatory requirement ahead of a potential biologics license application. The company said the plan covers the future evaluation of AP-SA02 as an adjunct treatment for complicated Staphylococcus aureus bacteremia in patients up to 17 years old. The FDA agreed that pediatric studies should be deferred until safety and efficacy data are available from its planned phase 3 adult trial, which Armata expects to begin in the second half of 2026, it added. Following the adult study, Armata said it plans to conduct a multicenter, open-label pediatric trial to assess the therapy's safety, tolerability and clinical response.
Armata Pharmaceuticals (ARMP) said Monday it has reached agreement with the US Food and Drug Administration on an agreed initial pediatric study plan for AP-SA02, clearing a regulatory requirement ahead of a potential biologics license application.
The company said the plan covers the future evaluation of AP-SA02 as an adjunct treatment for complicated Staphylococcus aureus bacteremia in patients up to 17 years old.
The FDA agreed that pediatric studies should be deferred until safety and efficacy data are available from its planned phase 3 adult trial, which Armata expects to begin in the second half of 2026, it added.
Following the adult study, Armata said it plans to conduct a multicenter, open-label pediatric trial to assess the therapy's safety, tolerability and clinical response.