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BioThrax

Phase 3

Anthrax | Monoclonal antibody | Other |Emergent BioSolutions Inc.|Last Updated: Jun 15, 2025

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
RandomizedCONTROLLEDBiomarker
Total Trials2
Total Enrollment354
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01491607Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy AdultsPHASE3 COMPLETED 200 — — Nov 1, 2011May 1, 2012Apr 9, 20244 United States
NCT01753115Ciprofloxacin BioThrax Co-Administration StudyPHASE2 COMPLETED 154 — — Dec 1, 2012Aug 1, 2013Jun 15, 20253 United States
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Study Endpoints
Primary Endpoints
Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28).
Day 63 +/- 2 days

Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.

Ratios of Ciprofloxacin Area Under the Curve and Cmax (Day 5/Day 44)
Day 5 and Day 44 in Arm 1

Ratios of Area Under the Curve from zero to 12 hours (AUC0-12h) and maximum concentration (Cmax) achieved for ciprofloxacin (Day 5/Day 44).

Secondary Endpoints
Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70.
Day 70 +/- 2 days
Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive).
Days 63 to 100
Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BioThrax (0.5 mL, on days 0, 14, and 28)EXPERIMENTAL -
BioThrax + Ciprofloxacin PKEXPERIMENTALBioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule. Ciprofloxacin: 500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48).
BioThrax + Ciprofloxacin no PKEXPERIMENTALBioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule. Ciprofloxacin: 500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48).
BioThrax onlyEXPERIMENTALBioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule.
Interventions
NameTypeDescription
BioThraxBIOLOGICALBioThrax, 0.5 mL administered subcutaneously on days 0, 14, and 28.
CiprofloxacinDRUG500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48).
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Be between 18 and 65 years of age, inclusive, at the time of enrollment. * Be in good health as determined by the investigator from medical history and a physical examination. * If a pre-menopausal female, must be using acceptable methods of birth control. * Have all hematolog...

Countries:United States
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