Lyra Therapeutics Reports Topline Results from Phase 3 ENLIGHTEN 1 Trial for LYR-210 in Chronic Rhinosinusitis - Seite 2

The ENLIGHTEN 1 trial is ongoing and data from the 52-week extension phase are expected in Q4 2024. ENLIGHTEN 2, the second pivotal Phase 3 trial of LYR-210 in CRS, is ongoing.

The Company expects to make near-term changes to its business operations and to reduce its workforce in order to preserve cash.

About the ENLIGHTEN 1 Trial

ENLIGHTEN 1 is a randomized, blinded, sham-controlled trial designed to evaluate the efficacy and safety of LYR-210 in patients with chronic rhinosinusitis (CRS) who have failed medical management and have not had prior ethmoid sinus surgery, randomized 2:1 to either LYR-210 or sham control for 24 weeks. At the end of the treatment phase, patients in the control group receive crossover LYR-210 treatment while patients in the LYR-210 group are re-randomized 1:1 to either receive a crossover sham-procedure or a repeat treatment with LYR-210 (7500 µg mometasone furoate); all patients are then followed through 52 weeks.

ENLIGHTEN 1 enrolled a total of 190 patients, approximately two-thirds from U.S. sites and one-third from sites in Europe. The mean baseline 3CS scores were 6.9 points and 6.7 points for treatment and sham control arms, respectively, and the mean SNOT-22 scores were 61 points in both the treatment and sham control arms. The baseline CT opacification scores were 44.9% and 47.3% for the treatment and sham control arms, respectively.

About LYR-210

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. LYR-210 is a bioabsorbable sinonasal implant that is designed to deliver six months of continuous anti-inflammatory medication (7500µg mometasone furoate) to the sinonasal passages for the treatment of CRS. CRS is a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities and is the fifth most common condition in people under age 65.

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.