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NCT05219968 (LYR-210 Sham procedure control… in Chronic Rhinosinusitis): BVCT ex-ante prediction vs. reported outcome

On 15 Dec 2023, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 6 May 2024 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
NCT05219968
Acronym
ENLIGHTEN 1
Drug Name
LYR-210 Sham procedure control Background Therapy
Drug MoA
long-acting glucocorticoid receptor agonist
Drug Modality
medical device
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Chronic Rhinosinusitis
Human Patients
196
Sponsor
Lyra Therapeutics
Phase
Phase 3

Prediction of , index 669

Prospective Prediction
Prediction Index
669
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
partial SUCCESS (statistically significant yet weak clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
143 days in advance
Readout Data Interpretation
3CS primary endpoint not met yet with positive trend (not significant).
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
ENLIGHTEN 1: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis (CRS) in Adults
Phase
Phase 3
Status
Completed
Enrollment
196
Lead sponsor
Lyra Therapeutics
Conditions
Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)
Interventions
DRUG: LYR-210; DRUG: Sham procedure control; OTHER: Background Therapy
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2022-01-27
Primary completion
2024-03-04
Completion
2024-09-16
Results first posted
2025-05-02
Primary outcomes
  • Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps. (24 Weeks)

NCT05219968 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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