LYR-220 24-Week Steroid-Eluting Sinus Insert Improves Smell and Sleep in Patients With Chronic Rhinosinusitis

Sunday, September 29, 2024

1:06 PM – 1:12 PM EDT

Location: MBCC, 230

Disclosure(s):

Vineeta S. Belanger, PhD:

faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Zachary M. Soler, MD, MSc:

faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Richard Nieman, MD:

faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Introduction: Chronic rhinosinusitis (CRS) patients suffer from an array of symptoms, often including smell and sleep impairments. LYR-220 is a 24-week mometasone furoate-eluting sinus insert in clinical development for the treatment of CRS patients who have continued symptoms despite prior ethmoid surgery. We have previously reported on the efficacy of LYR-220 in improving SNOT-22 total scores and the composite score of the 3 cardinal CRS symptoms. Here we report new, additional results on the effects of LYR-220 on the sense of smell and sleep quality from the BEACON study.

Methods: In total, 42 CRS patients with previous bilateral ethmoidectomy were enrolled between August 2022 and February 2023 in the multicenter, blinded, randomized, and controlled BEACON study (clinicaltrials.gov NCT05035654). Patients were randomized 1:1 to receive LYR-220 or sham procedure bilaterally in an in-office procedure. Loss of smell was assessed using a 0 to 3 scale, while sleep dysfunction was evaluated as a sub-domain of the SNOT-22 questionnaire. Changes from baseline in loss of smell in patients with impaired smell at baseline and SNOT-22 sleep dysfunction score in all patients were evaluated through week 28 and the treatment difference (LS Mean) and the 1-sided p-values were calculated using a Mixed Model Repeated Measures (MMRM).

Results: In patients with impaired smell at baseline, LYR-220 showed statistically significant improvement vs sham in the loss of smell as early as 8 weeks (-0.77, p = 0.014), which was sustained through the end of treatment at 24 weeks (-0.87, p = 0.026). Regardless of sleep quality at baseline, clinically and statistically significant reduction vs sham in SNOT-22 sleep dysfunction score was seen at week 8 (-3.6, p = 0.021) and sustained through the end of treatment at 24 weeks (-4.0, p = 0.02).

Conclusions: In this study, LYR-220 showed significant and sustained improvements in sense of smell and in sleep in patients with CRS.

Co-Author(s)

VB

Vineeta S. Belanger, PhD

SVP Clinical Affairs
Lyra Therapeutics
Waltham, MA, United States

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Presenting Author(s)

ZS

Zachary M. Soler, MD, MSc

Professor of Otolaryngology
Medical University of Sourth Carolina
Charleston, SC, United States

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Senior Author(s)

Robert C. Kern, MD

George A. Sisson Professor and Chairman
Northwestern University Feinberg School of Medicine
Chicago, IL, United States

Disclosure information not submitted.

Co-Author(s)

ML

Misun Lee, PhD

VP Biometrics
Lyra Therapeutics
Watertown, Massachusetts, United States

Disclosure information not submitted.
LB

Lindsay Brayton

Associate Director Clinical Operations
Lyra Therapeutics
Watertown, Massachusetts, United States

Disclosure information not submitted.
RN

Richard Nieman, MD

Chief Medical Officer
Lyra Therapeutics
Watertown, MA, United States

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.