Lyra Therapeutics (LYRA) said Monday that a phase 3 trial of LYR-210 bioabsorbable nasal implant met its primary and key secondary endpoints in patients with chronic rhinosinusitis.
The Enlighten 2 phase 3 study met its primary endpoint of statistically significant improvement in nasal obstruction, nasal discharge, and facial pain or pressure at week 24 in patients without nasal polyps, the company said.
Key secondary endpoints were also met, with LYR-210 achieving significant improvement in the three major symptoms at week 24 in patients with and without nasal polyps, and in the Sino-Nasal Outcome Test score starting at week 4 and through week 24, according to Lyra.
LYR-210 was well-tolerated with no product-related serious adverse events, the company said.
Lyra said it plans to work with the US Food and Drug Administration on a path to potential submission of a new drug application for LYR-210 in patients without nasal polyps and continue development for those with nasal polyps.
Shares of the company were up more than 490% in recent premarket activity Monday.
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