BioinvestGPT

BioinvestGPT ApS · Research use only

NCT04816721 (zelicapavir 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 9 Dec 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially TBD (wait for efficacy data).

Clinical Trial

NCTID
NCT04816721
Acronym
RSVPEDs
Drug Name
zelicapavir (EDP-938)
Drug MoA
RSV nucleoprotein inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Infections
Indication
respiratory syncytial virus (RSV)
Human Patients
96
Sponsor
Enanta Pharmaceuticals
Phase
Phase 2

Prediction of , index 1038

Prospective Prediction
Prediction Index
1038
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
213 days in advance
Readout Data Interpretation
zelicapavir achieved statistical significance in primary and secondary virology endpoints compared with placebo (peak 0.7-1.4 log viral load decline compared with placebo); no efficacy endpoint data has been disclosed.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially TBD (wait for efficacy data)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-PART STUDY TO EVALUATE EDP-938 REGIMENS IN SUBJECTS AGED 28 DAYS TO 36 MONTHS INFECTED WITH RESPIRATORY SYNCYTIAL VIRUS (RSV)
Phase
Phase 2
Status
Completed
Enrollment
99
Lead sponsor
Enanta Pharmaceuticals, Inc
Conditions
Respiratory Syncytial Virus (RSV)
Interventions
DRUG: EDP-938; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-04-26
Primary completion
2024-08-19
Completion
2024-08-19
Results first posted
2025-07-08
Primary outcomes
  • Part 1: Concentrations of EDP-938 in Plasma (3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5)
  • Part 1: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) (Day 1 to Day 28)
  • Part 2: Model-Adjusted Daily Change From Baseline in Respiratory Syncytial Virus (RSV) Shedding in Nasal Swab Samples (Baseline and pre-dose on Days 3, 5, 9, and 14)
  • Pooled Population: Model-Adjusted Daily Change From Baseline in RSV Shedding in Nasal Swab Samples (Baseline and pre-dose on Days 3, 5, 9, and 14)

NCT04816721 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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