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.

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