相关临床试验
5
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2005
已完成
5
100.0%
暂无批准数据
- Lyra Therapeutics has fully enrolled its pivotal Phase 3 ENLIGHTEN 2 trial evaluating LYR-210 for chronic rhinosinusitis (CRS) in adults without prior ethmoid sinus surgery. - LYR-210 is a bioresorbable nasal implant designed to deliver six months of continuous anti-inflammatory medication (mometasone furoate) directly to the sinonasal passages. - The ENLIGHTEN 2 trial randomized approximately 180 CRS patients 2:1 to either LYR-210 (7500μg mometasone furoate) or a sham control for a 24-week period. - Topline results from the ENLIGHTEN 2 trial are anticipated in the second quarter of 2025, marking a key milestone for Lyra Therapeutics.
- Lyra Therapeutics announced that its Phase 3 ENLIGHTEN 1 trial evaluating LYR-210, a bioabsorbable sinonasal implant for chronic rhinosinusitis, failed to meet its primary endpoint of demonstrating statistically significant improvement in cardinal symptoms compared to sham control at 24 weeks. - The trial enrolled 190 patients with chronic rhinosinusitis who had failed medical management and had not undergone prior ethmoid sinus surgery, with LYR-210 showing a mean improvement of 2.13 points in the composite symptom score versus 2.06 points for sham control. - Despite the setback, LYR-210 was generally well tolerated with no product-related serious adverse events, and the company continues its second Phase 3 trial ENLIGHTEN 2 while planning workforce reductions to preserve cash. - The failed trial represents a significant disappointment for addressing the estimated four million chronic rhinosinusitis patients in the United States who fail medical management annually and require further intervention.
