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AP-SA02

Phase 1

Bacteremia | Monoclonal antibody | Other |Armata Pharmaceuticals, Inc.|Last Updated: Mar 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05184764Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus BacteremiaPHASE1 COMPLETED 56 — — Apr 26, 2022Jan 14, 2025Mar 23, 202628 United States, Australia
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) Following Multiple Doses of Intravenous AP-Sa02.
Day 1 first dose through Day 12 or through EOS (28 days after BAT) (Day 39-81).

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.

Secondary Endpoints
Clinical Improvement or Response at Day 12
12 Days
Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy as Assessed by the Investigator
7 days post completion of best available antibiotic therapy, up to 60 days.
Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy Assessed by the CEAC
7 days post completion of best available antibiotic therapy, up to 60 days.
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 2a Complicated SAB - AP-SA02EXPERIMENTALAnti-staphylococcal bacteriophage
Phase 2a Complicated SAB- PlaceboPLACEBO_COMPARATORInactive Isotonic Saline Solution
Phase 1b Uncomplicated SAB - AP-SA02EXPERIMENTALAnti-staphylococcal bacteriophage
Phase 1b Uncomplicated SAB - PlaceboPLACEBO_COMPARATORInactive Isotonic Saline Solution
Interventions
NameTypeDescription
AP-SA02BIOLOGICALBacteriophage administered via intravenous bolus infusion
PlaceboOTHERInactive Placebo administered via intravenous bolus infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites28

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...

Countries:United StatesAustralia
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