Armata Pharmaceuticals, Inc. (NYSE American: ARMP), a US-based biotechnology company, announced on Tuesday that it has dosed its first subject in the Phase 2a portion of the company's diSArm study of AP-SA02 as a potential treatment for Staphylococcus aureus bacteraemia.
The company has commenced the Phase 2a portion of the study subsequent to Data Review Committee (DRC) review of positive safety and tolerability data from the Phase 1b portion.
The diSArm study, a Phase 1b/2a randomised, double-blind, placebo-controlled, multiple ascending dose escalation study, is intended to assess the safety, tolerability, and efficacy of intravenous AP-SA02 as an adjunct to best available antibiotic therapy compared to best available antibiotic therapy alone for the treatment of adults with bacteraemia because of Staphylococcus aureus.
This study is being carried out in two phases, Phase 1b assessed the safety and tolerability of multiple ascending intravenous doses of AP-SA02 or placebo as an adjunct to best available therapy (BAT) compared to BAT alone in subjects with SA bacteraemia (SAB). The Phase 2a is assessing the efficacy, safety, and tolerability of multiple doses of AP-SA02 or placebo as an adjunct to BAT compared to BAT alone in subjects with complicated SAB. The study is to enrol around 50 subjects.
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