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NCT05397665 (Govorestat in Hereditary Neuropathy Caused by SORD Deficiency): BVCT ex-ante prediction vs. reported outcome

On 2 Nov 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 18 May 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05397665
Acronym
INSPIRE
Drug Name
Govorestat (AT007)
Drug MoA
Aldose Reductase inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Hereditary Neuropathy Caused by SORD Deficiency
Human Patients
56
Sponsor
Applied Therapeutics
Phase
Phase 2 Phase 3

Prediction of , index 1313

Prospective Prediction
Prediction Index
1313
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
563 days in advance
Readout Data Interpretation
govorestat failed to deliver statistically significant 10MWRT improvement at month 12 compared with placebo
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically 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 RandomIzed, Double-Blind, Placebo-CoNtrolled, Two-Part Study to Evaluate the Pharmacodynamic EffIcacy and Clinical Benefit of AT 007 in Patients With SoRbitol Dehydrogenase (SORD) DEficiency
Phase
Phase 2, Phase 3
Status
Completed
Enrollment
56
Lead sponsor
Applied Therapeutics, Inc.
Conditions
Hereditary Neuropathy Caused by SORD Deficiency
Interventions
DRUG: AT-007; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-01-01
Primary completion
2024-10-12
Completion
2026-06-01
Primary outcomes
  • 10-meter walk-run test (10MWRT). (baseline and up to month 24)
  • Blood sorbitol levels (Baseline and up to 3 months.)

NCT05397665 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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