Lyra Therapeutics Announces Positive Topline Results from BEACON Phase 2 Study of LYR-220 for the Treatment of Chronic Rhinosinusitis (CRS) in Patients with Prior Ethmoid Sinus Surgery

Study demonstrates statistically significant and clinically relevant improvements in 3 Cardinal Symptoms and SNOT-22 scores at 24 weeks

Statistically significant improvements in efficacy were observed as early as 2 weeks

Primary endpoint met with no serious adverse events observed

LYR-220, Lyra’s second product candidate, is a long-acting anti-inflammatory therapy in development for CRS patients with and without polyps who have recurrent symptoms despite prior ethmoid sinus surgery

Conference call today at 8:00 a.m. ET.

WATERTOWN, Mass., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing innovative therapies for the localized treatment of chronic rhinosinusitis (CRS), today announced positive topline results from the BEACON Phase 2 clinical study of LYR-220 in adult patients with CRS, with and without polyps, who have had prior ethmoid sinus surgery. The study met its primary safety endpoint, with no serious adverse events observed. Most commonly reported adverse events included sinusitis, nasopharyngitis, bronchitis, and COVID-19.

LYR-220 significantly improved important patient reported outcome measures compared to sham control:

• Statistically significant improvement in a composite of the 3 cardinal symptoms of CRS (nasal obstruction, nasal discharge, facial pain/pressure) at week 24 (-1.50; p=0.02)
• Statistically significant improvements in Sino-Nasal Outcome Test (SNOT-22) score compared to sham control at week 24 (-16.8; p=0.007)
• Statistically significant improvement in a composite of the 3 cardinal symptoms of CRS (nasal obstruction, nasal discharge, facial pain/pressure) as early as week 4 (-0.87; p=0.037)
• Statistically significant improvements in SNOT-22 were observed as early as week 2 (-9.0; p=0.031)
• Improvements in SNOT-22 were sustained throughout the study and clinically meaningful with almost twice the minimal clinically important difference observed at week 24 compared to sham (-16.8 points)
  

LYR-220 is a bioresorbable nasal matrix designed to deliver six months of continuous anti-inflammatory medication (mometasone furoate; MF) to the sinonasal passages for the treatment of CRS. Topline results from the BEACON study of LYR-220 will be presented at the American Rhinologic Society (ARS) 69^th Annual Meeting on September 30, 2023, in Nashville, TN. Full results will be submitted for future publication.