Armata Advances Phage Therapy Candidate AP-SA02 to Phase 3 After Positive FDA Review

Reuters01-13

Armata Advances Phage Therapy Candidate AP-SA02 to Phase 3 After Positive FDA Review

Armata Pharmaceuticals Inc. has announced that its Phase 2a diSArm study demonstrated the first evidence of efficacy for phage therapy in a randomized controlled trial, targeting complicated Staphylococcus aureus bacteremia. Following feedback from the U.S. Food and Drug Administration (FDA) after an End-of-Phase 2 meeting, the FDA agreed that the safety and efficacy data support advancing Armata's bacteriophage product candidate, AP-SA02, to a Phase 3 clinical trial. Armata intends to initiate this pivotal superiority study later this year, which would be the first superiority-based pivotal trial for an antibacterial drug candidate in several decades. The company is currently addressing FDA recommendations on study design and manufacturing in preparation for the upcoming trial.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Armata Pharmaceuticals Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: LA62077) on January 13, 2026, and is solely responsible for the information contained therein.

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