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Lyra Therapeutics Announces It Will Present 52-Week Extension Stage Results For ENLIGHTEN 1 Phase 3 Study For LYR-210 For The Treatment of Chronic Rhinosinusitis At COSM May 14-18 2025 In New Orleans

Benzinga·05/07/2025 11:09:46
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  • Results from ENLIGHTEN 1 Phase 3 Extension Stage support LYR-210's favorable safety profile and general consistency with the Primary Study Phase in patients with CRS 
  • In the CRS patient subgroup with nasal polyps, analysis showed improvements in both symptoms and polyp size in Sham group patients that received crossover LYR-210
  • Lyra continues to focus on upcoming results from ENLIGHTEN 2 pivotal Phase 3 trial in CRS patients expected in 2Q 2025 

     

 Lyra Therapeutics, Inc. (NASDAQ:LYRA), ("Lyra" or the "Company"), a clinical-stage biotechnology company developing long-acting, anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis (CRS), today announced that the Company plans to present results from the 52-week Extension Stage of the ENLIGHTEN 1 Phase 3 study for LYR-210, the Company's lead product candidate for CRS, at the annual Combined Otolaryngology Spring Meetings (COSM 2025) being held May 14-18 in New Orleans.

The poster will present 52-week results from the Extension Stage of the ENLIGHTEN 1 study in patients with CRS, including the following highlights:

  • LYR-210 was generally well tolerated and no treatment-related serious adverse events reported through Week 52.
  • Repeat LYR-210 treatment demonstrated a favorable safety profile, similar to that observed in the Primary Study Stage in patients with CRS.
  • Durable symptom control through 52 weeks observed after LYR-210 treatment cessation (LYR-Sham group) in both non-polyp and polyp patients.
  • In non-polyp patients, despite showing a strong Sham effect in the Primary Study Stage, there was further meaningful improvement in symptoms in crossover patients that subsequently received LYR-210 in the Extension Stage.
  • In the CRS patient subgroup with nasal polyps, crossover Sham-LYR group improved in both symptoms and polyp size consistent with LYR-210 treatment in the Primary Study Stage.

     

The poster presentation on LYR-210 is planned to take place during these poster sessions at COSM 2025:

  • Poster TitleLYR-210 Sinonasal Corticosteroid Implants for Chronic Rhinosinusitis: 52-week outcomes from the Phase 3 ENLIGHTEN 1 trial

     
  • Location: Elite Exhibit Hall at the Hyatt Regency New Orleans

     
  • Date and Time: Poster Sessions, Fri., May 16 at 9:00 a.m.-7:00 p.m. CT and Sat., May 17 at 9:00 a.m.-4:00 p.m. CT

The ENLIGHTEN program consists of two pivotal Phase 3 clinical trials, ENLIGHTEN 1 and ENLIGHTEN 2, to evaluate the efficacy and safety of LYR-210 for the treatment of CRS. Each ENLIGHTEN trial enrolled approximately 180 CRS patients who have failed medical management and have not had prior ethmoid sinus surgery, randomized 2:1 to either LYR-210 (7500µg mometasone furoate) or sham control for 24 weeks.

About LYR-210

LYR-210 is an investigational product candidate for the treatment of chronic rhinosinusitis (CRS) in patients who have failed current therapies and require further intervention. LYR-210 is a bioabsorbable nasal implant designed to be inserted in a simple, in-office procedure. LYR-210 is intended to deliver six months of continuous anti-inflammatory therapy, mometasone furoate, to the sinonasal passages to treat CRS. LYR-210 is being evaluated in the ENLIGHTEN pivotal Phase 3 clinical program.