Lyra Therapeutics Reports Positive Results from the ENLIGHTEN 2 Phase 3 Trial of LYR-210 Achieving Statistically Significant Results for Primary and Key Secondary Endpoints in the Treatment of Chronic Rhinosinusitis (CRS)

Core Insights - Lyra Therapeutics announced positive results from the ENLIGHTEN 2 Phase 3 clinical trial of LYR-210 for chronic rhinosinusitis (CRS), achieving its primary endpoint with significant symptom improvement compared to sham control [1][4][5] Clinical Trial Results - The ENLIGHTEN 2 trial met its primary endpoint, showing a statistically significant improvement in the composite of the three cardinal symptoms (3CS) of CRS at week 24 (-1.13; p=0.0078) in patients without nasal polyps [1][5] - Key secondary endpoints were also met, including a significant improvement in 3CS at 24 weeks in the full population (-0.90; p=0.0209) and in the SNOT-22 score (-8.7; p=0.0101) [2][4] - Symptom improvement was observed as early as week 4, with sustained improvements throughout the trial [2][5] Safety and Tolerability - LYR-210 was well-tolerated, with a safety profile similar to sham control and no product-related serious adverse events reported [6] - Commonly reported adverse events included epistaxis, upper respiratory tract infection, and headache [6] Future Development Plans - The company plans to review the total dataset from the ENLIGHTEN trials to evaluate next steps for pursuing an indication in non-polyp patients and to continue development in patients with nasal polyps [4][7] - Lyra aims to align with the FDA for a New Drug Application (NDA) submission for patients without nasal polyps [7] Market Potential - LYR-210 is designed to provide six months of continuous anti-inflammatory therapy with a single administration, targeting the estimated four million CRS patients in the U.S. who fail medical management each year [12]