Slide 1: Long-acting corticosteroid matrices improve CRS cardinal symptoms
Long-acting corticosteroid matrices improve CRS cardinal symptoms Brent A. Senior, MD1*, Anders Cervin, MD, PhD2, Joanne Rimmer, MD3, Agnieszka Wrobel, MD, PhD4, Lindsay Brayton, BA5, James Shao, MS5, Vineeta Belanger, PhD5, Robert C. Kern, MD6 1Department of Otolaryngology - Head & Neck Surgery, Un
Slide 2: Forward-looking statements
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements, including statements regar
Slide 3: Disclosures
Brent A. Senior was the Chair of the Data Monitoring Committee for the Phase II LANTERN study and is a consultant of Lyra Therapeutics, Inc. and a consultant for Stryker. He is also Vice President for Development and Strategy for the American Rhinologic Society. DISCLOSURES
Slide 4: Background: CRS impacts patient quality of life
Chronic rhinosinusitis (CRS) is a disorder that significantly impacts the quality-of-life of patients Intranasal corticosteroids as first line therapy Estimated that up to 50% of CRS patients remain uncontrolled despite medical management1, indicating a need for better treatment options Composite sc
Slide 5: LYR-210 for chronic rhinosinusitis
Bioresorbable matrix formulated to provide steady daily dosing of mometasone furoate continuously over 24 weeks Administered bilaterally in an in-office procedure using endoscopic guidance Designed to conform to the middle meatus and adjust as tissues remodel Placement and removal procedure is well-
Slide 6: LANTERN study design
Multicenter, patient-blinded, randomized, controlled, dose-ranging Phase II study LANTERN STUDY DESIGN Study Population: Adults with CRS who failed previous medical management and have not undergone FESS Primary Endpoint: Change from baseline in the composite score of the 4 cardinal symptoms of CRS
Slide 7: Summary of previously reported LANTERN study results
Cervin A, et al. Int Forum Allergy Rhinol. 2022;12(2):147-159. Change from baseline (CFBL) in 3CS composite score was evaluated in a post-hoc analysis of the LANTERN study. P values are 1-sided vs. control. *p<0.05, **p<0.01. LYR-210 was well tolerated at both 7500µg and 2500µg doses and AEs were co
Slide 8: Improvement in 3CS composite scores from moderate or severe to none or mild
Improvement IN 3CS composite scores from Moderate or Severe at baseline to none or mild at week 24 Weekly 3CS composite scores were categorized as: none [0-1.5), mild [1.5-4.5), moderate [4.5-7.5), and severe [7.5-9]. LYR-210 (7500µg) (n=1) and LYR-210 (2500µg) (n=2) were excluded from analysis, as
Slide 9: Improvement in individual 3CS symptom scores at week 24
Improvement in 3CS scores from Moderate or Severe at baseline to none or mild at week 24 Weekly scores of individual symptoms were categorized as: none [0-0.5), mild [0.5-1.5), moderate [1.5-2.5), and severe [2.5-3]. LYR-210 (7500µg) (n=1) and LYR-210 (2500µg) (n=2) were excluded from analysis in (B
Slide 10: Conclusions
LYR-210 (7500µg) significantly improved the severity of nasal blockage, nasal discharge, and facial pain/pressure when analyzed as individual and composite symptom scores in the LANTERN study, achieving None or Mild at week 24 in some subjects LYR-210 demonstrated a dose response in improving 3CS se
Slide 11: Correlation between SNOT-22 and cardinal symptom composite scores in CRS
Correlation between SNOT-22 and cardinal symptom composite scores in CRS This data was presented at the 68th Annual Meeting of the ARS in Philadelphia, Pennsylvania. Saturday, September 10, 2022 (2:14-2:20pm ET) Session: Health Disparities, Disease Burden, and Patient Outcomes Brent A. Senior, MD1*,
Slide 12: Forward-looking statements
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements, including statements regar
Slide 13: Disclosures
Brent A. Senior was the Chair of the Data Monitoring Committee for the Phase II LANTERN study and is a consultant of Lyra Therapeutics, Inc. and a consultant for Stryker. He is also Vice President for Development and Strategy for the American Rhinologic Society. DISCLOSURES
Slide 14: Background: SNOT-22 and CRS endpoints
SNOT-22 is a routinely used CRS-specific quality of life instrument; however, it has not been accepted as a primary endpoint for evaluating response to treatments in development for CRS Clinical studies for CRSwNP have used change in nasal polyp score and change in nasal congestion score as primary
Slide 15: LYR-210 for chronic rhinosinusitis
Bioresorbable matrix formulated to release mometasone furoate at a steady rate continuously for up to 24 weeks Self-expanding properties allow LYR-210 to dynamically conform to the middle meatus Straightforward office-based placement and removal that is well-tolerated by patients LYR-210 FOR chronic
Slide 16: LANTERN study design
LANTERN STUDY DESIGN Multicenter, patient-blinded, randomized, controlled, dose-ranging Phase II study Cervin A, et al. Int Forum Allergy Rhinol. 2022;12(2):147-159. EOT = End of Treatment; EOS = End of Study; FESS = functional endoscopic sinus surgery. *CRS cardinal symptoms are nasal blockage, fac
Slide 17: Previously reported LANTERN study results
Both doses of LYR-210 demonstrated safety and were well-tolerated LYR-210 (7500µg) achieved statistically significant symptom improvements at Week 24 19-point improvement over Control in SNOT-22 1.6-point improvement over Control in 3CS composite scores PREVIOUSLY REPORTED Lantern study results SNOT
Slide 18: LANTERN study: improvement in 3CS composite scores at week 24
3CS Scale: 0-9 points. Proportion of subjects with a ≥ 1-point or ≥ 2-point improvement in 3CS composite score at week 24. P values are 1-sided vs. Control; *p<0.01. Lantern study: improvement in 3cs composite scores at week 24
Slide 19: Correlation between SNOT-22 total and 3CS composite scores at week 24
The change from baseline in SNOT-22 total score and 3CS composite score at Week 24 are strongly (r=0.76) and significantly (p<0.0001) correlated Change from baseline in SNOT-22 Total Score vs. 3CS composite score at Week 24. N=40 subjects. LANTERN STUDY: Correlation between SNOT-22 total & 3CS compo
Slide 20: Correlation between SNOT-22 rhinologic domain and 3CS composite scores
The change from baseline in SNOT-22 rhinologic domain score and 3CS composite score at Week 24 are strongly (r=0.78) and significantly (p<0.0001) correlated Change from baseline in SNOT-22 Rhinologic Domain Score vs. 3CS composite score at Week 24. N=40 subjects. LANTERN STUDY: Correlation between S
Slide 21: Conclusions
Improvement in 3CS composite scores at Week 24 appeared to be dose-dependent, with LYR-210 (7500µg) achieving statistical significance compared to Control in the LANTERN study Change from baseline in 3CS composite score strongly and significantly correlates with the change in SNOT-22 total and rhino