Armata Pharmaceuticals, Inc. (ARMP), a clinical-stage biotechnology company, Monday announced positive topline results from its Phase 1b/2a diSArm study evaluating AP-SA02 for the treatment of Staphylococcus aureus bacteremia. The study met its primary goals.
Staphylococcus aureus bacteremia (SAB) is a serious bloodstream infection caused by the bacteria Staphylococcus aureus.
AP-SA02 is a novel multi-phage therapeutic, which uses bacteriophages, or viruses that infect bacteria, to treat bacterial infections. The diSArm study was a multiple ascending dose escalation study to evaluate the safety, tolerability, and efficacy of AP-SA02 in addition to best available antibiotic therapy (BAT) compared to BAT alone for the treatment of adults with complicated SAB.
All primary endpoints for safety, tolerability, and clinical response in the intent-to-treat population were met. Treatment with AP-SA02 significantly improved clinical outcomes and prevented relapse compared to best available antibiotic. Further, no treatment-related serious adverse events were observed.
"These data, including the favorable safety profile of AP-SA02, warrant that we move as rapidly as possible towards initiation of a pivotal trial," said Deborah Birx, Chief Executive Officer of Armata.
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