Slide 1: LYR-210 Sinonasal Implants for CRS: Results from the Phase 3 ENLIGHTEN 2 Study
LYR-210 Sinonasal Implants for Chronic Rhinosinusitis (CRS): Results from the Phase 3 ENLIGHTEN 2 Study Zachary M. Soler, MD, MSc
Slide 2: Disclaimer / Forward Looking Statements
Disclaimer / Forward Looking Statements This presentation is intended for scientific and educational purposes only and is not intended to promote any unapproved use of LYR-210. The data presented herein are from the ENLIGHTEN 2 Phase 3 clinical trial and are subject to further verification and peer
Slide 3: LYR-210 Sinonasal Implants for CRS: Results from the Phase 3 ENLIGHTEN 2 Study
LYR-210 Sinonasal Implants for Chronic Rhinosinusitis (CRS): Results from the Phase 3 ENLIGHTEN 2 Study LYR-210 improves symptoms and QOL in patients with CRS Authors: Zachary M. Soler1, Jivianne Lee2, Robert M. Naclerio3, Brent A. Senior4, Robert C. Kern5, Abby Dudek6, Misun Lee6, Vineeta Belanger6
Slide 4: Disclosure Information
DISCLOSURE INFORMATION • Standards for Integrity and Independence in Accredited Continuing Education The AAO-HNSF is committed to creating high-quality education that is independent of industry influence. All persons who have been in control of this educational content for this accredited CE activit
Slide 5: LYR-210 Drug-Eluting Sinonasal Implant
LYR-210 Drug-Eluting Sinonasal Implant LYR-210: For CRS patients who have failed medical management and require further intervention Polymer-Drug Complex Designed to deliver 6 months of continuous, local drug therapy with a single placement In Vitro Drug Release Profile Designed to Deliver SUSTAIN
Slide 6: In-Office Placement of LYR-210
In-Office Placement of LYR-210 LYR-210 bilaterally placed in the middle meatus of a patient with CRS
Slide 7: ENLIGHTEN 2: Pivotal Phase 3 Trial
ENLIGHTEN 2: Pivotal Phase 3 Trial • 24-week, multi-center, randomized, sham-controlled, blinded trial • Adult CRS patients who failed prior medical management and have not previously undergone ethmoid sinus surgery. • Non-polyp and a subset of 29 polyp grade 1 ENLIGHTEN 2 Study Design • 172 patient
Slide 8: Participant Baseline Characteristics
Participant Baseline Characteristics ITT Analysis Set LYR-210 Sham (N=172) (n=111) (n=61) Age in years (mean, SD) 50 (15.5) 49 (13.0) Sex (n, %) Male 65 (58.6%) 31 (50.8%) Female 46 (41.4%) 30 (49.2%) Race (n, %) White 94 (84.7%) 51 (83.6%) Black or African American 9 (8.1%) 5 (8.2%) Region (n, %) N
Slide 9: Most Frequent Adverse Events (≥5% of participants)
Most Frequent Adverse Events (≥5% of participants) Favorable safety profile with no product-related serious adverse events reported LYR-210 (n=112*) Sham (n=60*) Safety Analysis Set (Preferred Term1) n (%) n (%) Any treatment-emergent adverse events (TEAEs) 68 (60.7%) 26 (43.3%) Epistaxis2 18 (16.1%
Slide 10: Primary Endpoint: Change from Baseline in 3CS at Week 24
Primary Endpoint: Change from Baseline in 3CS at Week 24 [p a ti e n ts w i th o u t n a s a l p o l yp s ] The primary endpoint was met with statistically significant improvement in 3CS at 24 weeks Consistent improvement over Sham control observed as early as Week 8 Change in 3CS Change in 3CS
Slide 11: Individual Cardinal Symptoms
Individual Cardinal Symptoms [p a ti e n ts w i th o u t n a s a l p o l yp s ] Consistent improvement observed in all 3 individual components of 3CS in patients without nasal polyps Change in Nasal Change in Nasal Change in Facial Congestion at Week 24 Discharge at Week 24 Pain/Pressure at Week 2
Slide 12: Change from Baseline in SNOT-22
Change from Baseline in SNOT-22 [p a ti e n ts w i th o r w i th o u t n a s a l p o l yp s ] Statistically significant improvement in SNOT-22 score at 24 weeks, with robust improvement starting at Week 4 LYR-210 group improved by 22.4 points – more than 2-fold the MCID Change in SNOT-22 at Week
Slide 13: Change from Baseline in SNOT-22 Subdomain Scores
Change from Baseline in SNOT-22 Subdomain Scores [patients with or without nasal polyps] LYR-210 showed improvements over sham in all subdomains of SNOT-22 Change in Rhinologic Change in Extra-Nasal Change in Ear/Facial Change in Change in Symptoms Rhinologic Symptoms Symptoms Psychological Dysfun
Slide 14: Improvement over Sham in Other Key Secondary Endpoints
Improvement over Sham in Other Key Secondary Endpoints CFBL in 3CS in the overall population (polyp and non-polyp participants) showed statistically significant improvement over Sham control CFBL in the % ethmoid opacification by 3D volumetric analysis of CT demonstrated a numerical improvement
Slide 15: Large Treatment Effect in Patients with Higher CT Disease
Large Treatment Effect in 3CS and SNOT-22 Observed in Patients with Higher CT Disease CRS without Nasal Polyps with Baseline Ethmoid Opacification >25%* Change in 3CS Change in SNOT-22 0 0 -4.02 -0.77 -5 LS Mean CFBL in SNOT-22 Score LS Mean CFBL in 3CS Score -1 -10 -2 -15 -2.54 -23.3 p=0.0048 p=0.0
Slide 16: CT of LYR-210 group Participant Pre and Post Treatment
CT of LYR-210 group Participant Pre and Post Treatment Screening Week 20
Slide 17: Summary of ENLIGHTEN 2 Results
Summary of ENLIGHTEN 2 Results • ENLIGHTEN 2 study met its primary endpoint − Statistically significant improvement over sham in 3CS at Week 24 in the primary population of CRS patients without nasal polyps, with improvement observed as early as Week 8. − Improvements observed in all 3 individual ca