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VX-222

Phase 2

Chronic Hepatitis C Virus | Small molecule | Infectious Disease |Vertex Pharmaceuticals Incorporated|Last Updated: Oct 20, 2014

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
RandomizedCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment167
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01581138VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis CPHASE2 COMPLETED 64 — — Jul 1, 2012Dec 1, 2013Jul 4, 201418 United States
NCT01516918A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated CirrhosisPHASE2 COMPLETED 103 — — Feb 1, 2012Dec 1, 2013Oct 20, 201443 United States, Canada +3
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Study Endpoints
Primary Endpoints
The proportion of subjects who have a sustained viral response (SVR) at 12 weeks after the last planned dose of treatment
12 weeks after the last planned dose of treatment
The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12)
12 weeks
Secondary Endpoints
The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis)
up to 20 weeks
The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug
24 weeks after the last planned dose of the study drug
The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug
4 weeks after the last planned dose of the study drug
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
12 week treatmentEXPERIMENTAL -
16 week treatmentEXPERIMENTAL -
Quadruple RegimenEXPERIMENTALAll subjects will receive active study drugs (quadruple regimen: VX-222, telaprevir,Peg-IFN, and RBV) for a fixed treatment duration of 24 weeks.
Interventions
NameTypeDescription
VX-222DRUG400 mg tablets twice daily for oral administration
telaprevirDRUG1125 mg tablets twice daily for oral administration
ribavirinDRUG1000 mg per day for subjects weighing \<75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily
peginterferon-alfa-2aBIOLOGICALsubcutaneous injection, 180-mcg, once weekly
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Subjects must have genotype 1 chronic hepatitis C (CHC) and laboratory evidence of HCV infection for at least 6 months before the Screening Visit * Subjects will be treatment naïve * Subjects must have documentation of the presence or absence of cirrhosis Exclusion Criteria: ...

Countries:United StatesCanadaGermanyPolandUnited Kingdom
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