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NCT06122662 (AMX0035 in Progressive Supranuclear Palsy): BVCT ex-ante prediction vs. reported outcome

On 26 Apr 2025, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 27 Aug 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
NCT06122662
Acronym
ORION
Drug Name
AMX0035
Drug MoA
sodium phenylbutyrate + taurursodiol
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Progressive Supranuclear Palsy
Human Patients
110
Sponsor
Amylyx Pharmaceuticals
Phase
Phase 3

Prediction of , index 1375

Prospective Prediction
Prediction Index
1375
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in PSPRS though no FDA approved drug is available)
Technical Prediction
FAILURE (statistically maybe significant yet very weak clinical benefit in PSPRS compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
123 days in advance
Readout Data Interpretation
AMX0035 failed to meet any primary or secondary endpoint; further development discontinued
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 Phase 2b/3 Study of the Safety and Efficacy of AMX0035 in Progressive Supranuclear Palsy (ORION)
Phase
Phase 2, Phase 3
Status
Completed
Enrollment
139
Lead sponsor
Amylyx Pharmaceuticals Inc.
Conditions
Progressive Supranuclear Palsy; PSP; Neurodegenerative Diseases; Atypical Parkinsonism
Interventions
DRUG: AMX0035; OTHER: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-12-21
Primary completion
2025-09-30
Completion
2025-10-21
Primary outcomes
  • Change in total (28-item) Progressive Supranuclear Palsy Rating Scale (PSPRS) Score (52 weeks)

NCT06122662 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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