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VX-787

Phase 2

Influenza Virus | Small molecule | Infectious Disease |Vertex Pharmaceuticals Incorporated|Last Updated: Sep 2, 2016

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment140
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01561807A Study to Investigate VX-787 Given to Adult Volunteers Inoculated With Live Influenza VirusPHASE2 COMPLETED 140 — — Mar 1, 2012 -Sep 2, 20161 United Kingdom
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Study Endpoints
Primary Endpoints
The primary endpoint is viral AUC as calculated in cell culture of nasal swabs (quantitation of nasal swabs for viral infectivity by cell culture), from initiation of VX-787 treatment
up to 11 days
Secondary Endpoints
Safety and tolerability based on assessment of adverse events, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), and vital signs.
up to 33 days
Total tissue count and total mucus weight after viral inoculation
up to 10 days
Sequence analysis of the relevant target region of influenza
up to 8 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
787 low doseEXPERIMENTALVX-787 low dose capsule, taken orally for 5 days
787 high doseEXPERIMENTALVX-787 high dose capsule, taken orally for 5 days
Placebo low doseEXPERIMENTALMatching placebo low dose capsule, taken orally for 5 days
Placebo high doseEXPERIMENTALMatching placebo high dose capsule, taken orally for 5 days
Interventions
NameTypeDescription
VX-787DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Negative human immunodeficiency virus (HIV), hepatitis B (HBV) and hepatitis C(HCV) antibody screen * Have not been vaccinated for influenza virus since 2006 or had a known influenza-like illness in the current season (as determined in the medical history), defined as in the l...

Countries:United Kingdom
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