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 being developed for bacteremia, specifically Staphylococcus aureus bacteremia. It is being studied in patients with S. aureus bloodstream infections. The drug is administered intravenously and is currently in Phase 1 clinical development.
AP-SA02 is a monoclonal antibody designed to target Staphylococcus aureus, the bacteria responsible for S. aureus bacteremia. By targeting this pathogen, the antibody aims to help the immune system clear the infection. It is being evaluated for safety, tolerability, and efficacy in patients with S. aureus bacteremia.
AP-SA02 is being developed by Armata Pharmaceuticals, Inc., a biopharmaceutical company traded on the stock market under the ticker symbol ARMP. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating Staphylococcus aureus bacteremia.
AP-SA02 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing to assess its safety, tolerability, and potential efficacy.
AP-SA02 has one completed clinical trial registered under NCT05184764, titled 'Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia.' This Phase 1 study enrolled 56 participants in the United States and Australia, and it was a randomized, double-blind, placebo-controlled trial.
AP-SA02 is a distinct investigational monoclonal antibody developed by Armata Pharmaceuticals. It is not known to be the same as any other approved or marketed drug. Its unique mechanism targets Staphylococcus aureus for the treatment of bacteremia, and it is being studied under its own clinical trial program.