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NCT06347159 (EDG-7500 in Hypertrophic Cardiomyopathy): BVCT ex-ante prediction vs. reported outcome

On 12 May 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 19 Sep 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT06347159
Acronym
CIRRUS-HCM
Drug Name
EDG-7500
Drug MoA
oral selective cardiac sarcomere modulator
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Hypertrophic Cardiomyopathy (HCM)
Human Patients
55
Sponsor
Edgewise Therapeutics
Phase
Phase 1 Phase 2

Prediction of , index 1601

Prospective Prediction
Prediction Index
1601
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit with maybe-superior to-CK274 and superior-to-metoprolol-succinate efficacy in LVOT-G)
Technical Prediction
SUCCESS (statistically significant clinical benefit in LVOT-G)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
130 days in advance
Readout Data Interpretation
EDG7500 achieved 67% mean reduction in resting LVOT-G and 55% mean reduction in provokable LVOT-G at day 10; which are superior to aficamten's 44.8% mean reduction in provokable LVOT-G at week 12 (DOI- 10.1056/NEJMoa2401424)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
An Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-7500 in Adults With Hypertrophic Cardiomyopathy
Phase
Phase 2
Status
Active not recruiting
Enrollment
79
Lead sponsor
Edgewise Therapeutics, Inc.
Conditions
Hypertrophic Cardiomyopathy
Interventions
DRUG: EDG-7500; DRUG: EDG-7500
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2024-04-11
Primary completion
2027-12
Completion
2027-12
Primary outcomes
  • Incidence of treatment-emergent adverse events (From screening through study completion (Part A: Up to 38 days; Part B and C: Up to 73 days; Part D: Up to 18 months))

NCT06347159 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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