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NCT05842941 (DNL343 in Amyotrophic Lateral Sclerosis): BVCT ex-ante prediction vs. reported outcome

On 27 Feb 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 6 Jan 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
NCT05842941
Acronym
HEALEY
Drug Name
DNL343
Drug MoA
transferrin-receptor-mediated BBB-crossing EIF2beta activator
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Amyotrophic Lateral Sclerosis
Human Patients
249
Sponsor
Denali Therapeutics / AbbVie
Phase
Phase 2 Phase 3

Prediction of , index 1487

Prospective Prediction
Prediction Index
1487
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
314 days in advance
Readout Data Interpretation
DNL343 failed to achieve its primary efficacy endpoint
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
HEALEY ALS Platform Trial - Regimen G DNL343
Phase
Phase 2, Phase 3
Status
Completed
Enrollment
249
Lead sponsor
Merit E. Cudkowicz, MD
Conditions
Amyotrophic Lateral Sclerosis
Interventions
DRUG: DNL343; DRUG: Matching Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-05-24
Primary completion
2024-10-29
Completion
2024-10-29
Results first posted
2026-01-28
Primary outcomes
  • Disease Progression as Assessed by the ALSFRS-R-Slope (Baseline to 24 Weeks)
  • Mortality Event Rate (Baseline to 24 weeks)

NCT05842941 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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