Lyra announces Phase 3 ENLIGHTEN 1 trial did not meet primary endpoint

Lyra Therapeutics announced topline results from the Company’s Phase 3 ENLIGHTEN 1 trial evaluating LYR-210 for the treatment of chronic rhinosinusitis. ENLIGHTEN 1 did not meet its primary endpoint of demonstrating statistically significant improvement compared to sham control in the composite score of the three cardinals symptom of CRS at 24 weeks. ENLIGHTEN 1 is one of two Phase 3 clinical trials evaluating LYR-210, a bioabsorbable sinonasal implant, as a six-month treatment for chronic rhinosinusitis. At 24 weeks, the ENLIGHTEN 1 trial demonstrated the following results compared to baseline, which did not achieve statistical significance: In the primary efficacy analysis, treatment with LYR-210 resulted in a mean improvement in the 3CS score of 2.13 points, compared to 2.06 points in sham control. In the intent-to-treat population, treatment with LYR-210 resulted in a mean improvement in the 3CS score of 2.35 points, compared to 1.89 points in sham control. In the ITT population, treatment with LYR-210 resulted in a mean improvement in the Sino-Nasal Outcome Test score of 20.2 points, compared to 15.70 points in sham control. Ethmoid sinus opacification, did not achieve statistically significant improvement after treatment with LYR-210 compared to sham control.