Lyra Therapeutics Kickstarts LYR-210 Pivotal Program in Surgically Naïve Chronic Rhinosinusitis Patients

Lyra Therapeutics Inc 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.