Lyra Therapeutics, Inc. (LYRA), Monday announced positive results from the ENLIGHTEN 2 Phase 3 clinical trial of LYR-210 in adult patients with chronic rhinosinusitis, achieving primary and key secondary endpoints.
The trial met its primary endpoint with LYR-210 demonstrating statistically significant improvement in the composite of the three cardinal symptoms or 3CS - nasal obstruction, nasal discharge, and facial pain/pressure, at week 24.
Additionally, the trial met the key secondary endpoints of 3CS in the full population at 24 weeks with symptom improvement observed as early as week 4.
The company noted that LYR-210 was well tolerated, with no product-related serious adverse events in the trial.
Lyra further shares insights from pooled data of LYR-210 from ENLIGHTEN 2 and ENLIGHTEN 1 trials in 64 CRS patients with nasal polyps, demonstrating a consistent positive trend over 24 weeks in multiple key efficacy endpoints.
Based on these data, the company plans to align with the FDA to move forward for an NDA submission in patients without nasal polyps.
Moreover, Lyra intends to review the totality of the dataset from the ENLIGHTEN trials to evaluate next steps for pursuing an indication in non-polyp patients, as well as to continue development of LYR-210 in patients with nasal polyps.
Notably, the findings from the ENLIGHTEN 2 trial of LYR-210 will be presented at the 71st Annual Meeting of the American Rhinologic Society to be held in October 2025.
In the pre-market hours, Lyra's stock is surging 510.55 percent, to $29.85 on the Nasdaq.
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