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NCT06170242 (EDP-323 in RSV Infection): BVCT ex-ante prediction vs. reported outcome

On 10 May 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 26 Sep 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (yet moderate benefit with negative dose-response relationship) and commercially TBD.

Clinical Trial

NCTID
NCT06170242
Drug Name
EDP-323
Drug MoA
RSV L-protein inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Infections
Indication
RSV Infection
Human Patients
114
Sponsor
Enanta Pharmaceuticals
Phase
Phase 2

Prediction of , index 1590

Prospective Prediction
Prediction Index
1590
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit with non-superior-to-palivizumab efficacy)
Technical Prediction
SUCCESS (statistically significant yet moderate clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
139 days in advance
Readout Data Interpretation
EDP323 achieved 78%-66% reduction in total symptom score AUC (p<0.0001) featuring a negative dose-response relationship; without disclosure of RSV LRTD symptom resolution or all-cause mortality data.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (yet moderate benefit with negative dose-response relationship) and commercially TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Randomized, Phase 2a, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of Orally Administered EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy Adults
Phase
Phase 2
Status
Completed
Enrollment
142
Lead sponsor
Enanta Pharmaceuticals, Inc
Conditions
RSV Infection
Interventions
DRUG: EDP-323 Dose Regimen 1; DRUG: EDP-323 Dose Regimen 2; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2023-11-20
Primary completion
2024-06-17
Completion
2024-07-12
Results first posted
2025-10-07
Primary outcomes
  • Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR): RSV Area Under the Viral Load-time Curve (VL-AUC) (Day 1 to Day 12)

NCT06170242 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials