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NCT05291091 (Sevasemten in Becker Muscular Dystrophy): BVCT ex-ante prediction vs. reported outcome

On 6 Aug 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 16 Dec 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (TNNI2) and commercially insufficient (NSAA).

Clinical Trial

NCTID
NCT05291091
Acronym
CANYON
Drug Name
Sevasemten (EDG-5506)
Drug MoA
oral selective fast skeletal muscle myosin inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Musculoskeletal Diseases
Indication
Becker Muscular Dystrophy
Human Patients
170
Sponsor
Edgewise Therapeutics
Phase
Phase 2

Prediction of , index 1251

Prospective Prediction
Prediction Index
1251
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in either NSAA or 6MWD)
Technical Prediction
SUCCESS (statistically significant clinical benefit in TNNI2)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
132 days in advance
Readout Data Interpretation
sevasemten achieved 77% reduction in plasma TNNI2 (p<0.001); sevasemten failed to achieved statistically significant improvement in NSAA (p=0.16).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (TNNI2) and commercially insufficient (NSAA)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of EDG-5506 on Safety, Biomarkers, Pharmacokinetics, and Functional Measures in Adults and Adolescents With Becker Muscular Dystrophy
Phase
Phase 2
Status
Completed
Enrollment
244
Lead sponsor
Edgewise Therapeutics, Inc.
Conditions
Becker Muscular Dystrophy
Interventions
DRUG: Sevasemten 10 mg; DRUG: Sevasemten 5 mg; DRUG: Sevasemten 12.5 mg; DRUG: Placebo
Design
Randomized · Sequential · Quadruple
Primary purpose
Treatment
Start
2022-11-10
Primary completion
2026-09-07
Completion
2026-09-07
Primary outcomes
  • Number of treatment emergent adverse events in those treated with sevasemten or placebo (12 months (CANYON Cohorts 1, 2, 4, 5), 18 months (GRAND CANYON Cohort 6))
  • Severity of treatment emergent adverse events in those treated with sevasemten or placebo (12 months (CANYON Cohorts 1, 2, 4, 5), 18 months (GRAND CANYON Cohort 6))
  • Change from Baseline in serum Creatine Kinase (Averaged across Months 6, 9, 12 Months (CANYON Cohorts 1, 2))
  • Change from Baseline in total North Star Ambulatory Assessment score (18 months (GRAND CANYON Cohort 6))

NCT05291091 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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