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Kamada AAT for

Phase 2

Emphysema | Monoclonal antibody | Respiratory |Kamada Ltd.|Last Updated: Nov 29, 2019

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment168
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01217671International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients With EmphysemaPHASE2 COMPLETED 168Dec 1, 2009Jun 1, 2015Nov 29, 201912 Canada, Denmark +5
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Study Endpoints
Primary Endpoints
Exacerbation events and lung density
Approximately 1 year
Secondary Endpoints
Adverse Events
Approximately 1 year
Vital Signs
Approximately 1 year
Physical Examination
Approximately 1 year
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Alpha-1 AntitrypsinEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Kamada AAT for inhalationBIOLOGICALAlpha-1 Antitrypsin (AAT)
PlaceboOTHERPlacebo
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Principal Inclusion Criteria: * Diagnosis of emphysema confirmed by CT scan. If a report of past CT scan is not available at site documenting then a CT scan is to be performed at screening * Male or female patients at least 18 years of age. * Able and willing to sign an informed consent. * Patient ...

Countries:CanadaDenmarkGermanyIrelandNetherlandsSwedenUnited Kingdom
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