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NCT05169580 (Pociredir in sickle cell disease): BVCT ex-ante prediction vs. reported outcome

On 25 Jun 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 29 Jul 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically probably insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05169580
Acronym
PIONEER
Drug Name
Pociredir
Drug MoA
EED-PRC2 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Hemic and Lymphatic Diseases
Indication
sickle cell disease
Human Patients
70
Sponsor
Fulcrum Therapeutics
Phase
Phase 1

Prediction of , index 1630

Prospective Prediction
Prediction Index
1630
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit with high toxicity)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
399 days in advance
Readout Data Interpretation
Pociredir achieved 16% HbF response at week 12 that are strongly inferior to Casgevy's 37% HbF response at week 12 (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably 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 Phase 1 Open-Label, Multiple-Dose Study to Evaluate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of FTX-6058 in Subjects With Sickle Cell Disease (SCD)
Phase
Phase 1
Status
Completed
Enrollment
45
Lead sponsor
Fulcrum Therapeutics
Conditions
Sickle Cell Disease; Sickle Cell Anemia
Interventions
DRUG: Pociredir oral capsule(s)
Design
Sequential · None
Primary purpose
Treatment
Start
2021-12-13
Primary completion
2026-01-20
Completion
2026-01-20
Primary outcomes
  • Treatment-Emergent Adverse Events (Up to approximately 16 weeks of monitoring)
  • Plasma Concentrations of Pociredir (Days 1, 14, 28, 42, 56, 70, 84 and 91)

NCT05169580 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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