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LYR-210 · 3 trials · 2 indications
The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.
The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.
Participants score their CS symptoms on a 4-point scale as follows: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom present but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The scores are summed and averaged over the proceeding 7 days; higher scores indicate higher severity of symptoms of CS.
| Arm | Type | Description |
|---|---|---|
| LYR-210 | EXPERIMENTAL | Single administration of LYR-210 drug matrix (7500 μg) |
| Sham procedure control | SHAM_COMPARATOR | Single mock administration procedure |
| LYR-210 (Low Dose) | EXPERIMENTAL | In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus |
| LYR-210 (High Dose) | EXPERIMENTAL | In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus |
| Sham Procedure | SHAM_COMPARATOR | In-office bilateral sham procedure |
| Name | Type | Description |
|---|---|---|
| LYR-210 | DRUG | LYR-210 drug matrix (mometasone furoate) |
| Sham procedure control | DRUG | Sham procedure control |
| Background therapy | OTHER | Daily Saline Irrigation |
| Sham comparator | OTHER | Sham comparator |
Inclusion Criteria: * Age ≥18 * Diagnosed as having CRS * Bilateral ethmoid disease confirmed on CT * Mean 3 cardinal symptom (3CS) score * Undergone at least 2 trials of medical treatments in the past * Has been informed of the nature of the study and provided written informed consent * Agrees to ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE3 | Itepekimab |
| AstraZeneca PLC | AZN | 4 | PHASE3 | Tezepelumab |
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | - | Undisclosed |
LYR-210 is an investigational small molecule being developed for chronic sinusitis, also referred to as chronic rhinosinusitis, in adults. It is delivered as a depot formulation and is currently in clinical development, having completed Phase 3 trials. LYR-210 is not approved by the FDA and remains investigational.
LYR-210 is being developed by Lyra Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol LYRA. The company is focused on ENT (ear, nose, and throat) therapies and has advanced LYR-210 through Phase 3 clinical trials for chronic sinusitis.
LYR-210 is in Phase 3 clinical development for chronic sinusitis. Three clinical trials have been completed, including two Phase 3 studies and one Phase 2 study. As of now, LYR-210 is investigational and has not received FDA approval.
LYR-210 has completed three clinical trials: NCT04041609 (LANTERN Study, Phase 2), NCT05219968 (Phase 3), and NCT05295459 (ENLIGHTEN 2, Phase 3). These trials enrolled a total of 449 adults with chronic sinusitis and were randomized, double-blind, and sham-controlled.
Yes, LYR-210 is also referred to as LYR-210 Depot in clinical trial documentation. The LANTERN Study (NCT04041609) specifically uses the name LYR-210 Depot. Both names refer to the same investigational drug product being developed for chronic sinusitis.