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NCT05085561 (REC-994 in Cerebral Cavernous Malformation): BVCT ex-ante prediction vs. reported outcome

On 11 May 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 5 May 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
NCT05085561
Acronym
SYCAMORE
Drug Name
REC-994
Drug MoA
superoxide dismutase small molecule mimetic
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Cerebral Cavernous Malformation (CCM)
Human Patients
62
Sponsor
Recursion Pharmaceuticals
Phase
Phase 2

Prediction of , index 1591

Prospective Prediction
Prediction Index
1591
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit with inferior-to-microsurgery/radiosurgery efficacy)
Technical Prediction
partial SUCCESS (statistically maybe significant yet very weak clinical benefit with a negative dose-response relationship)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
359 days in advance
Readout Data Interpretation
REC994 failed to achieve statistically significant improvement in efficacy whose further development has thus been discontinued
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 Two-Part Study of REC-994 in the Treatment of Adults With Symptomatic Cerebral Cavernous Malformation (CCM); Part 1: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Two Doses of REC-994; Part 2: A Long-Term Blinded Extension Clinical Trial to Evaluate Long-Term Safety Tolerability and Efficacy of REC-994
Phase
Phase 2
Status
Completed
Enrollment
62
Lead sponsor
Recursion Pharmaceuticals Inc.
Conditions
Cerebral Cavernous Malformation
Interventions
DRUG: REC-994; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-03-17
Primary completion
2025-06-30
Completion
2025-06-30
Primary outcomes
  • Incidence and severity of adverse events (AEs) (Up to 24 months)

NCT05085561 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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