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NCT05295459 (LYR210 in Chronic Rhinosinusitis): BVCT ex-ante prediction vs. reported outcome

On 27 Mar 2025, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 2 Jun 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (yet weak efficacy) and commercially probably insufficient (inferior to dupilumab).

Clinical Trial

NCTID
NCT05295459
Acronym
ENLIGHTEN 2
Drug Name
LYR210
Drug MoA
long-acting glucocorticoid receptor agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Chronic Rhinosinusitis
Human Patients
182
Sponsor
Lyra Therapeutics
Phase
Phase 3

Prediction of , index 670

Prospective Prediction
Prediction Index
670
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in 3CS)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in 3CS compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
67 days in advance
Readout Data Interpretation
LYR210 achieved statistically significant clinical benefit in 3CS (-0.90; p=0.00209) and SNOT22 reduction (-8.7 p=0.0101) at week 24 in patients with/without nasal polyps; inferior to dupilumab’s -14 placebo-adjusted SNOT22 reduction at week 24 (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (yet weak efficacy) and commercially probably insufficient (inferior to dupilumab)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
ENLIGHTEN 2: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults
Phase
Phase 3
Status
Completed
Enrollment
182
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
2022-05-13
Primary completion
2025-04-02
Completion
2025-04-02
Results first posted
2026-02-19
Primary outcomes
  • Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps (Week 24)

NCT05295459 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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