Lyra Therapeutics Falls 87% as Chronic Rhinosinusitis Study Fails to Meet Primary Endpoint

 Shares in clinical-stage biotechnology company, Lyra Therapeutics (Nasdaq: LYRA), have dropped more than 87% in morning trading on Monday after the company announced that its ENLIGHTEN-1 study of LYR-210 in the treatment of chronic rhinosinusitis (CRS) had failed to meet its primary endpoint. The company said in a statement that it will evaluate the trial’s full dataset and decide on a path forward.

ENLIGHTEN 1 is one of two Phase 3 clinical trials evaluating LYR-210, a bioabsorbable sinonasal implant (7500µg mometasone furoate), as a six-month treatment for CRS.

“We are surprised and disappointed by the ENLIGHTEN 1 topline results,” said Maria Palasis, Ph.D., President and Chief Executive Officer, Lyra Therapeutics. “We are moving as quickly as possible to evaluate the full dataset to better understand these findings in order to determine our path forward.”

LYR-210 is an investigational product candidate for the treatment of chronic rhinosinusitis (CRS) for up to four million CRS patients in the U.S. who fail current therapies annually and require further intervention. ENLIGHTEN 1 is an ongoing randomized, blinded, sham-controlled trial evaluating the safety and efficacy of LYR-210 in 190 patients at sites in the US and Europe. The study did not meet its primary endpoint of demonstrating statistically significant improvement compared to sham control in nasal obstruction, nasal discharge, facial pain/pressure.

About Lyra Therapeutics

Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing long-acting, anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis (CRS). Lyra Therapeutics has two product candidates, LYR-210 and LYR-220, in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210 and LYR-220 are bioabsorbable nasal implants designed to be administered in a simple, in-office procedure and are intended to deliver six months of continuous anti-inflammatory drug therapy (7500µg mometasone furoate) to the sinonasal passages for the treatment of CRS with a single administration. LYR-210, being evaluated in the ENLIGHTEN Phase 3 clinical program, has a smaller dimension and is intended for patients with standard anatomy, primarily patients who have not undergone ethmoid sinus surgery. LYR-220 is a larger implant designed for CRS patients whose nasal cavity is enlarged due to previous ethmoid sinus surgery. These two product candidates are designed to treat the estimated four million CRS patients in the United States who fail medical management each year. For more information, please visit www.lyratx.com and follow us on LinkedIn.