Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05035654 | LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study) | PHASE2 | COMPLETED | 48 | — | — | Nov 23, 2021 | Aug 30, 2023 | Dec 17, 2024 | 25 | United States, Australia |
Product-related unexpected serious adverse events
Plasma MF concentrations at 1 hour post study treatment administration and at Days 2 or 3, days 5 or 8, and Weeks 4,12,16 or 20, 24 and 25. The PK analysis will be performed based on subjects with available plasma MF concentration data post Day 1 administration procedure.
| Arm | Type | Description |
|---|---|---|
| Part 1: Treatment Arm LYR-220 Design 1 | EXPERIMENTAL | Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 |
| Part 1 and Part 2: Treatment Arm LYR-220 Design 2 | EXPERIMENTAL | Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 |
| Part 2: Treatment Arm Bilateral sham procedure control | SHAM_COMPARATOR | Bilateral sham procedure control |
| Name | Type | Description |
|---|---|---|
| LYR-220 Design 1 (Part 1 only) | DRUG | LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 |
| LYR-220 Design 2 (Part 1 and Part 2) | DRUG | LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 |
| Bilateral sham procedure control (Part 2) | DRUG | Bilateral sham procedure control |
Inclusion Criteria: * Diagnosis of chronic rhinosinusitis. * Has had a prior bilateral total ethmoidectomy. * Has computed tomography (CT) ethmoid cavity opacification. * Has a Sinonasal Outcome Test (SNOT-22) ≥ 20 at Screening Visit. * Minimum cardinal symptom score. * Has been informed of the nat...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Itepekimab, Mometasone furoate, lunsekimig |
| AstraZeneca PLC | AZN | 4 | PHASE3 | Tezepelumab |
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | — | Undisclosed |