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Aurexis

Phase 2

Staphylococcus Aureus Bacteremia | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Mar 29, 2013

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00198302Clinical Trial Comparing Safety and Pharmacokinetics of Standard Antibiotic Therapy, Plus Aurexis® or Placebo, for Treatment of Staphylococcus Aureus Bacteremia (SAB)PHASE2 COMPLETED 60 — — -Feb 1, 2005Mar 29, 2013 - —
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Study Endpoints
Primary Endpoints
• To evaluate the safety of standard of care, plus a single dose of Aurexis® compared to a single dose of placebo, in subjects with documented SAB
• To evaluate the pharmacokinetics of a single dose of Aurexis® in combination with standard of care in the subjects with SAB
• To evaluate the activity of a single dose of Aurexis® in combination with standard of care, as measured by:
o number of subjects with uncomplicated SAB at baseline who progress to complicated SAB
o number of subjects with microbiologically documented relapse of SAB
o mortality rates
Secondary Endpoints
• To evaluate the effect of a single dose of Aurexis® in combination with standard of care on the:
o proportion of subjects who develop sepsis, severe sepsis, or septic shock
o time to achieve a negative blood culture
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
Interventions
NameTypeDescription
Aurexis®DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Male or female, age ≥ 18 years old * Informed consent obtained from subject or legal guardian * Willing to practice reliable birth control measures during the study period * Diagnosis of SAB, as evidenced by clinical symptoms and one positive blood culture obtained ≤ 72 hours ...

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