Recent Updates
Recently added Catalysts

EDP239

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Enanta Pharmaceuticals, Inc.|Last Updated: Jan 29, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01856426Proof of Concept Study for Safety and Efficacy of EDP239 in Hepatitis C SubjectsPHASE1 COMPLETED 28Jun 1, 2013Oct 1, 2015Jan 29, 20165 United States, Germany
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change from baseline Hepatitis C viral load at Day 1
baseline, day 1

Blood will be collected for Hepatitis C viral load at Day 1.

Secondary Endpoints
Number of participants with adverse events as a measure of safety
14 days
Change from baseline in HCV RNA log
baseline, Day 1
Total concentration in plasma of EDP239 in HCV Gentoype 1 infected subjects
baseline, day 1
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1- EDP239EXPERIMENTALEDP239 given once a day.
PlaceboPLACEBO_COMPARATOR1 treatment arm will be placebo, dose given once a day.
2- EDP239EXPERIMENTALEDP239 given once a day.
3-EDP239EXPERIMENTALEDP239 given once a day.
4-EDP239EXPERIMENTALEDP239 given once a day.
Interventions
NameTypeDescription
EDP239DRUG -
PlaceboDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Subjects must have chronic genotype-1 hepatitis C virus infection and plasma HCV-RNA ≥ 105 IU/mL at the time of screening. * Subjects must have chronic HCV infection as determined by any of the following: * be anti-HCV (+) for at least 6 months per subject history or medical r...

Countries:United StatesGermany
Unlock Eligibility Criteria
Competitive Landscape -Hepatitis C 11 trials