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NCT05248230 (4D-710 in Cystic Fibrosis): BVCT ex-ante prediction vs. reported outcome

On 11 May 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 6 Jun 2024 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
NCT05248230
Acronym
CF
Drug Name
4D-710
Drug MoA
aerosol delivered human-mAb-resistant AAV transgene payload expressing CFTR
Drug Modality
gene therapy
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Cystic Fibrosis
Human Patients
24
Sponsor
4D Molecular Therapeutics
Phase
Phase 1 Phase 2

Prediction of , index 1005

Prospective Prediction
Prediction Index
1005
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
26 days in advance
Readout Data Interpretation
achieved 5-6% ppFEV1 from baseline by month 12; which is inferior to vertex's SoC's 14% improvement in 4 weeks.
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
An Open-label, Phase 1/2 Trial of Gene Therapy 4D-710 in Adults With Cystic Fibrosis
Phase
Phase 2
Status
Recruiting
Enrollment
30
Lead sponsor
4D Molecular Therapeutics
Conditions
Cystic Fibrosis Lung
Interventions
BIOLOGICAL: 4D-710
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-03-29
Primary completion
2027-06
Completion
2031-06
Primary outcomes
  • Incidence and severity of adverse events (60 Months)

NCT05248230 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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