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EDP239

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

EDP239 · 1 trial · 1 indication

Phase 1 1
NCT01856426Proof of Concept Study for Safety and Efficacy of EDP239 in Hepatitis C SubjectsHepatitis C
COMPLETED28 Analytics
PHASE1COMPLETED
Proof of Concept Study for Safety and Efficacy of EDP239 in Hepatitis C Subjects
Hepatitis C
NCT0185642628
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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
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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 -
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Eligibility Criteria

Age Range18 Years to 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
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Competitive Landscape -Hepatitis C 11 trials

CompanyTickerTrialsLead PhaseDrugs
Atea Pharmaceuticals, Inc.AVIR2PHASE3Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir
Abbott LaboratoriesABT2 - Undisclosed
AbbVie, Inc.ABBV1 - Undisclosed
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Frequently asked questions about EDP239

What is EDP239 used for in Hepatitis C?

EDP239 is an investigational small molecule being developed for the treatment of Hepatitis C. It is currently in Phase 1 clinical development and has been studied in a proof-of-concept trial to evaluate its safety and efficacy in subjects with Hepatitis C.

What does EDP239 target?

EDP239 is a small molecule being developed by Enanta Pharmaceuticals for Hepatitis C. Its specific molecular target has not been disclosed in the available information, so the exact mechanism of action is not detailed here.

Who makes EDP239?

EDP239 is being developed by Enanta Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ENTA. The company is conducting clinical research on this investigational drug for Hepatitis C.

What phase is EDP239 in?

EDP239 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy in patients with Hepatitis C.

What clinical trials is EDP239 in?

EDP239 has been studied in one completed Phase 1 clinical trial with the identifier NCT01856426. This proof-of-concept study evaluated the safety and efficacy of EDP239 in 28 subjects with Hepatitis C and was conducted in the United States and Germany.

Is EDP239 the same as any other drug?

EDP239 is not known to have any alternative names. It is a distinct investigational small molecule being developed by Enanta Pharmaceuticals for the treatment of Hepatitis C, and no other names for this drug have been identified.