Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AP-SA02 · 1 trial · 5 indications
Incidence and severity of treatment-emergent adverse events as assessed by CTCAE v4.0. Per SAP, all patients with uncomplicated SAB (Phase 1 Cohort 1 and Cohort 2) will be combined.
| Arm | Type | Description |
|---|---|---|
| Phase 2a Complicated SAB - AP-SA02 | EXPERIMENTAL | Anti-staphylococcal bacteriophage |
| Phase 2a Complicated SAB- Placebo | PLACEBO_COMPARATOR | Inactive Isotonic Saline Solution |
| Phase 1b Uncomplicated SAB - AP-SA02 | EXPERIMENTAL | Anti-staphylococcal bacteriophage |
| Phase 1b Uncomplicated SAB - Placebo | PLACEBO_COMPARATOR | Inactive Isotonic Saline Solution |
| Name | Type | Description |
|---|---|---|
| AP-SA02 | BIOLOGICAL | Bacteriophage administered via intravenous bolus infusion |
| Placebo | OTHER | Inactive Placebo administered via intravenous bolus infusion |
Key Inclusion Criteria: * A hospitalized female or male ≥ 18 years old * Positive blood culture for Staphylococcus aureus (SA) * Source of SA infection controlled, or a plan for source control, if relevant * Not pregnant or breastfeeding and is not of reproductive potential or agrees to use contrac...
AP-SA02 is an investigational monoclonal antibody developed by Armata Pharmaceuticals for the treatment of Staphylococcus aureus bacteremia, a serious bloodstream infection. It is designed as a targeted antibacterial therapy and has received Fast Track, Qualified Infectious Disease Product, and Breakthrough Therapy designations from the FDA.
AP-SA02 is being developed to treat Staphylococcus aureus bacteremia, a bloodstream infection caused by S. aureus. It is intended for patients with this condition and is given intravenously. The program is investigational and has not been approved for commercial use.
AP-SA02 targets Staphylococcus aureus, the bacterium responsible for the bloodstream infection it is being developed to treat. It is a monoclonal antibody directed against this pathogen, falling within the bacteriophage-derived target class. This targeted approach aims to address S. aureus bacteremia specifically rather than relying on broad-spectrum antibacterial activity.
AP-SA02 is being developed by Armata Pharmaceuticals, Inc., a biotechnology company whose common stock trades under the ticker symbol ARMP. Armata is the sponsor of the clinical program evaluating AP-SA02 in patients with Staphylococcus aureus bacteremia.
AP-SA02 is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The completed Phase 1 trial enrolled 56 patients and was randomized, double-blind, and placebo-controlled, evaluating safety, tolerability, and efficacy in Staphylococcus aureus bacteremia.
AP-SA02 has been studied in one clinical trial, NCT05184764, titled a study evaluating the safety, tolerability, and efficacy of intravenous AP-SA02 in subjects with S. aureus bacteremia. That Phase 1 trial is completed and enrolled 56 participants across the United States and Australia, in adults 18 years and older.