Lyra Therapeutics Kickstarts LYR-210 Pivotal Program in Surgically Naïve Chronic Rhinosinusitis Patients
Lyra Therapeutics Inc (NASDAQ: LYRA) has initiated its Phase 3 ENLIGHTEN I trial of LYR-210 in adult, surgically naïve chronic rhinosinusitis (CRS) patients.
LYR-210 is designed to be administered in a brief, non-invasive, in-office procedure and deliver up to six months of continuous anti-inflammatory medication to the sinonasal passages.
ENLIGHTEN I will evaluate LYR-210 compared to control in approximately 180 patients who have failed medical management and have not had prior sinus surgery.
The trial's primary endpoint is the change from baseline in a composite score of three cardinal symptoms (3CS) of CRS (i.e., nasal blockage, nasal discharge, and facial pain) at week 24.
Enrollment is anticipated to be complete in 1H of 2023
The Company plans to initiate ENLIGHTEN II, the second Phase 3 study of LYR-210, in 1H of 2022.
For LYR-220 in CRS adult patients who have had prior surgery for their CRS symptoms, the BEACON Phase 2 trial has been initiated.
The BEACON trial will compare two designs of LYR-220 to control over 24 weeks in approximately 70 subjects who have had prior bilateral sinus surgery.
Enrollment will complete by the end of 2022.
Price Action: LYRA shares are down 7.16% at $3.50 during the market session on the last check Monday.
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