BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05021536 (AMX0035 in Amyotrophic Lateral Sclerosis): BVCT ex-ante prediction vs. reported outcome

On 18 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 8 Mar 2024 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05021536
Acronym
Phoenix
Drug Name
AMX0035
Drug MoA
sodium phenylbutyrate + taurursodiol
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Amyotrophic Lateral Sclerosis
Human Patients
600
Sponsor
Amylyx Pharmaceuticals
Phase
Phase 3

Prediction of , index 342

Prospective Prediction
Prediction Index
342
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
19 days in advance
Readout Data Interpretation
endpoints not met.
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal modelling of ALS that has been permanently corrected.
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

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

Official title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients With Amyotrophic Lateral Sclerosis (ALS)
Phase
Phase 3
Status
Unknown
Enrollment
664
Lead sponsor
Amylyx Pharmaceuticals Inc.
Conditions
Amyotrophic Lateral Sclerosis
Interventions
OTHER: Placebo; DRUG: AMX0035
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-10-28
Primary completion
2024-01-19
Completion
2026-01-01
Primary outcomes
  • Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Slope Change (48 weeks)

NCT05021536 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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