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NCT05568706 (EDP-938 in Respiratory Syncytial Virus): BVCT ex-ante prediction vs. reported outcome

On 10 May 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 29 Sep 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically partially insignificant and commercially probably insufficient.

Clinical Trial

NCTID
NCT05568706
Acronym
RSVHR
Drug Name
EDP-938 (zelicapavir)
Drug MoA
RSV N-protein inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Infections
Indication
Respiratory Syncytial Virus (RSV)
Human Patients
186
Sponsor
Enanta Pharmaceuticals
Phase
Phase 2

Prediction of , index 1036

Prospective Prediction
Prediction Index
1036
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
507 days in advance
Readout Data Interpretation
zelicapavir failed to meet the primary endpoint in the time to resolution of the LRTD subset of four symptoms while meeting multiple secondary endpoints in PGI-S score and 2-day faster resolution
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically partially insignificant and commercially probably insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of EDP-938 in Non-hospitalized Adults With Acute Respiratory Syncytial Virus Infection Who Are at High Risk for Complications
Phase
Phase 2
Status
Completed
Enrollment
187
Lead sponsor
Enanta Pharmaceuticals, Inc
Conditions
RSV Infection
Interventions
DRUG: EDP-938; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2022-11-29
Primary completion
2025-06-23
Completion
2025-06-23
Results first posted
2026-08-19
Primary outcomes
  • Time to Resolution of RSV Lower Respiratory Tract Disease (LRTD) Symptoms (Day 1 through Day 33)
  • Time to Complete Resolution of LRTD Symptoms for the mITT Population (Day 1 through Day 33)
  • Time to Complete Resolution of LRTD Symptoms for the HR3 Population (Day 1 through Day 33)

NCT05568706 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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