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NCT05582395 (Mavacamten in non-obstructive hypertrophic cardiomyopathy): BVCT ex-ante prediction vs. reported outcome

On 2 Apr 2025, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 14 Apr 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
NCT05582395
Acronym
ODYSSEY-HCM
Drug Name
Mavacamten
Drug MoA
cardiac myosin inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
non-obstructive hypertrophic cardiomyopathy (nHCM)
Human Patients
580
Sponsor
Bristol-Myers Squibb
Phase
Phase 3

Prediction of , index 1959

Prospective Prediction
Prediction Index
1959
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient yet weak clinical benefit in KCCQ moderately inferior to aficamten)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in KCCQ compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
12 days in advance
Readout Data Interpretation
mavacamten failed to meet either the KCCQ-23 CSS or the pVO2 primary endpoints
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 Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Phase
Phase 3
Status
Terminated
Enrollment
580
Lead sponsor
Bristol-Myers Squibb
Conditions
Cardiomyopathy, Hypertrophic
Interventions
DRUG: Mavacamten; OTHER: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2022-12-14
Primary completion
2025-03-06
Completion
2025-10-20
Results first posted
2026-08-20
Primary outcomes
  • Change From Baseline in KCCQ-23 CSS at Week 48 (From First dose to week 48)
  • Change From Baseline in pVO2 at Week 48 (From First dose to week 48)

NCT05582395 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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