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BMS-791325

Phase 2

Hepatitis C Virus | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Oct 9, 2015

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01193361Ph IIA Study (SOC +/- NS5B)PHASE2 COMPLETED 39 — — Oct 1, 2010Nov 1, 2012Oct 9, 201510 United States
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Study Endpoints
Primary Endpoints
Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Formal analysis at week 4 (and upon occurrence)
Antiviral activity, as determined by the proportion subjects with eRVR
Week 4
Secondary Endpoints
Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV RNA
Week 4
Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA
Week 12
Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up
Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirinEXPERIMENTAL -
Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirinEXPERIMENTAL -
Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirinPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
BMS-791325DRUGTablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response
PlaceboDRUGTablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response
Peg-interferon alfa-2aDRUGSyringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
RibavirinDRUGTablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Subjects chronically infected with HCV genotype 1 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to Screening, and positive for HCV RNA and anti-HCV antibody at Screening * HCV RNA ≥ 10\*5\* IU/mL at Screening...

Countries:United States
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