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EDP-938 Dose 1

Phase 2

RSV Infection | Small molecule | Infectious Disease |Enanta Pharmaceuticals, Inc.|Last Updated: May 3, 2022

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment179

FDA Designations

No designations recorded

Clinical trial landscape

EDP-938 Dose 1 · 1 trial · 1 indication

Phase 2 1
NCT03691623A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge ModelRSV Infection
COMPLETED179 Analytics
PHASE2COMPLETED
A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model
RSV InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load
Twice daily on Day 2 through Day 11 and once on Day 12

Measured in nasal washes by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in participants inoculated with respiratory syncytial virus-A (RSV-A) Memphis 37b.

Secondary Endpoints

Area Under the Curve (AUC) of Total Symptom Score
Three times daily on Day 0 to Day 11, once on Day 12
Peak Total Symptom Score
Day 2 to Day 12
Total Symptom Score
Day 2 to Day 9
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EDP-938 Arm AEXPERIMENTALSubjects will take EDP-938 Dose 1 oral suspension for 5 days
EDP-938 Arm BEXPERIMENTALSubjects will take EDP-938 Dose 2 oral suspension for 5 days
Placebo Arm CPLACEBO_COMPARATORSubjects will take matching placebo oral suspension for 5 days
EDP-938 Arm DEXPERIMENTALSubjects will take EDP-938 Dose 3 oral suspension for 5 days
EDP-938 Arm EEXPERIMENTALSubjects will take EDP-938 Dose 4 oral suspension for 5 days
Placebo Arm FPLACEBO_COMPARATORSubjects will take matching placebo oral suspension for 5 days

Interventions

NameTypeDescription
EDP-938 Dose 1DRUGOral suspension for 5 days
EDP-938 Dose 2DRUGOral suspension for 5 days
PlaceboDRUGOral suspension for 5 days
EDP-938 Dose 3DRUGOral suspension for 5 days
EDP-938 Dose 4DRUGOral suspension for 5 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * An informed consent document signed and dated by the subject * Age 18 to 55 years, inclusive * In good health with no history of major medical conditions * A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m\^2 and ≤ 30kg/m\^2 Exclusion Criteria: * Pregnant or nu...

Countries:United Kingdom
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Frequently asked questions about EDP-938 Dose 1

What is EDP-305 Dose 1 used for?

EDP-305 Dose 1 is an investigational small molecule being studied for the treatment of Non-Alcoholic Steatohepatitis (NASH) and RSV Infection. It is being developed by Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA). The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does EDP-305 Dose 1 target?

EDP-305 Dose 1 is a small molecule being developed for Non-Alcoholic Steatohepatitis and RSV Infection. The specific molecular target has not been disclosed in available information. The drug is currently in Phase 2 clinical trials to evaluate its safety, tolerability, pharmacokinetics, and efficacy.

Who makes EDP-305 Dose 1?

EDP-305 Dose 1 is being developed by Enanta Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ENTA. The company is conducting clinical trials to evaluate the drug's potential in treating Non-Alcoholic Steatohepatitis and RSV Infection.

What phase is EDP-305 Dose 1 in?

EDP-305 Dose 1 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is being studied for Non-Alcoholic Steatohepatitis and RSV Infection, with completed Phase 2 trials in both indications.

What clinical trials is EDP-305 Dose 1 in?

EDP-305 Dose 1 has been studied in two completed Phase 2 clinical trials. NCT03421431 assessed the drug in 134 subjects with Non-Alcoholic Steatohepatitis across multiple countries. NCT03691623 evaluated EDP-938, a related compound, in 179 healthy volunteers using an RSV challenge model in the United Kingdom.

Is EDP-305 Dose 1 the same as EDP-938?

EDP-305 Dose 1 and EDP-938 are distinct investigational compounds developed by Enanta Pharmaceuticals. EDP-305 Dose 1 is being studied for Non-Alcoholic Steatohepatitis, while EDP-938 was evaluated in an RSV challenge model. Both are small molecules in Phase 2 development, but they are not the same drug.