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NCT05445323 (LX2006 in Friedreich's Ataxia): BVCT ex-ante prediction vs. reported outcome

On 7 Jul 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 15 Jul 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically maybe significant yet weak clinical benefit and commercially insufficient.

Clinical Trial

NCTID
NCT05445323
Acronym
SUNRISE-FA
Drug Name
LX2006
Drug MoA
AAVrh10-based gene therapy that deliver human FXN gene to cardiac cells
Drug Modality
gene therapy
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Friedreich's Ataxia
Human Patients
9
Sponsor
Lexeo Therapeutics
Phase
Phase 1 Phase 2

Prediction of , index 1664

Prospective Prediction
Prediction Index
1664
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in cardiac fibrosis/cardiac arrhythmia/exercise tolerance)
Technical Prediction
partial SUCCESS (statistically maybe significant yet very weak clinical benefit in cardiac fibrosis/cardiac arrhythmia/exercise tolerance despite significantly increasing FXN expression level)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
8 days in advance
Readout Data Interpretation
11.4% LVMI reduction at month 12; which falls in the lower end of the minimal clinically meaningful improvement threshold of 10-15% reduction in LVMI over 6 to 12 months.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically maybe significant yet weak clinical benefit 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 Study of the Safety and Efficacy of LX2006 Gene Therapy in Participants With Cardiomyopathy Associated With Friedreich's Ataxia
Phase
Phase 1, Phase 2
Status
Active not recruiting
Enrollment
8
Lead sponsor
Lexeo Therapeutics
Conditions
Friedreich Ataxia; Cardiomyopathy, Secondary
Interventions
GENETIC: Low dose LX2006; GENETIC: Mid Dose LX2006; GENETIC: High Dose LX2006
Design
Sequential · None
Primary purpose
Treatment
Start
2022-08-24
Primary completion
2029-09
Completion
2029-09
Primary outcomes
  • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious events (TESAEs) (Change from baseline to end of year 5 post dose)

NCT05445323 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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