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NCT05668741 (VX-522 in cystic fibrosis): BVCT ex-ante prediction vs. reported outcome

On 21 Aug 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 4 May 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically probably insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05668741
Drug Name
VX-522
Drug MoA
LNP-mediated CTFR mRNA medicine
Drug Modality
mRNA medicine
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
cystic fibrosis
Human Patients
26
Sponsor
Moderna / Vertex
Phase
Phase 1 Phase 2

Prediction of , index 1480

Prospective Prediction
Prediction Index
1480
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
partial SUCCESS (statistically significant clinical benefit in phase 1 toxicity endpoint) partial FAILURE (statistically maybe significant yet weak clinical benefit in phase 3 efficacy endpoint)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
621 days in advance
Readout Data Interpretation
VX-522's further development has been discontinued.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1/2 Dose Escalation Study Evaluating the Safety, and Tolerability and Efficacy of VX-522 in Subjects 18 Years of Age and Older With Cystic Fibrosis and a CFTR Genotype Not Responsive to CFTR Modulator Therapy
Phase
Phase 1, Phase 2
Status
Active not recruiting
Enrollment
26
Lead sponsor
Vertex Pharmaceuticals Incorporated
Conditions
Cystic Fibrosis
Interventions
DRUG: VX-522 mRNA therapy; DRUG: IVA
Design
Sequential · None
Primary purpose
Treatment
Start
2023-02-27
Primary completion
2026-04-21
Completion
2026-09-09
Primary outcomes
  • Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From Day 1 Through Week 8 [SAD and MAD])

NCT05668741 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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