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NCT06752668 (ORX750 in Narcolepsy and Idiopathic Hypersomnia): BVCT ex-ante prediction vs. reported outcome

On 8 Feb 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 5 Nov 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (stronger efficacy in NT1 than in NT2/IH) and commercially probably sufficient.

Clinical Trial

NCTID
NCT06752668
Acronym
CRYSTAL-1
Drug Name
ORX750
Drug MoA
OX2R agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Narcolepsy and Idiopathic Hypersomnia
Human Patients
96
Sponsor
Centessa Pharmaceuticals
Phase
Phase 2

Prediction of , index 1907

Prospective Prediction
Prediction Index
1907
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in MWT for NT1 NT2 and IH in observance of differential therapeutic windows (narrow range of high dose for NT2 medium range of medium dose for IH broad range of low dosage for NT1); non-superior to ALKS2680/TAK861 in the best-case scenarios of optimal dosing regimens)
Technical Prediction
SUCCESS (statistically significant clinical benefit in MWT for NT1 NT2 and IH compared with placebo; featuring a differential positive dose-response relationship (NT1 >> IH > NT2) and a differential positive dose-toxicity relationship (NT2 > IH)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
270 days in advance
Readout Data Interpretation
ORX750 1.5mg for NT1 achieved a >20 minute change from baseline in mean sleep latency compared with placebo on the MWT at Week 2 (p=0.0026). ORX750 4mg for NT2 achieved a >10 minute change from baseline in mean sleep latency compared with placebo on the MWT at Week 2 (p=0.0193). ORX750 2mg for IH achieved placebo-adjusted improvement in mean sleep latency compared with placebo on the MWT at Week 2 (p=0.0213)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (stronger efficacy in NT1 than in NT2/IH) and commercially probably sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORX750 in Subjects With Narcolepsy and Idiopathic Hypersomnia (CRYSTAL-1)
Phase
Phase 2
Status
Recruiting
Enrollment
248
Lead sponsor
Centessa Pharmaceuticals (UK) Limited
Conditions
Narcolepsy Type 1; Narcolepsy Type 2; Idiopathic Hypersomnia
Interventions
DRUG: ORX750; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2024-12-23
Primary completion
2026-12
Completion
2026-12
Primary outcomes
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs (Up to Day 35)
  • Number of Participants With Abnormal Changes From Baseline in Laboratory Tests (Up to Day 35)
  • Number of Participants With Abnormal Change From Baseline in Vital Signs (Up to Day 35)
  • Number of Participants With Abnormal Change From Baseline in Electrocardiograms (ECG) (Up to Day 35)
  • Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) (Up to Day 35)

NCT06752668 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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