ENT and Allergy Associates Conducting Clinical Trial of Investigational LYR-210 Treatment for Chronic Rhinosinusitis (CRS) Patients

Tarrytown, New York, June 09, 2022 (GLOBE NEWSWIRE) — ENT and Allergy Associates, LLP (ENTA), the largest ear, nose, throat, allergy, and audiology practice in the nation, which continuously strives to encourage and promote the very best medical advancements in the fields of otolaryngology, allergy, and audiology announced today that it is currently participating in the international ENLIGHTEN I Phase 3 clinical trial evaluating LYR-210, a flexible bioresorbable drug matrix designed by Lyra Therapeutics, Inc. to be placed inside the nasal passages where it gradually releases mometasone furoate for up to 24 weeks, in chronic rhinosinusitis (CRS) patients.

This clinical study will be led by Dr. Moshe Ephrat, who is at the forefront of clinical research. Dr. Ephrat is a fellowship-trained and board-certified ENT surgeon practicing at the Lake Success office of ENTA. He has over 20 years of ENT expertise with specialized interests in nasal and sinus surgery and is consistently among the first in the area to offer new breakthrough medical technologies. The Lake Success office, which is located at 6 Ohio Drive, Lake Success, NY, 11042, is currently screening and enrolling subjects for this clinical study.

Dr. Ephrat has academic appointments as an Assistant Clinical Professor for the Zucker School of Medicine at Hofstra/Northwell.

Lyra Therapeutics, Inc. is a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, local delivery of medications to diseased tissues not accessible with conventional therapeutic approaches. Lyra’s product candidate, LYR-210 is comprised of a bioresorbable polymeric drug matrix formulated to locally deliver continuous mometasone furoate directly to the sinonasal mucosa for up to 24 weeks. LYR-210 is intended to be bilaterally administered using topical anesthesia in a straightforward in-office visit.

The ENLIGHTEN I study is a phase III, randomized, controlled, blinded trial to evaluate the efficacy and safety of LYR-210 in adults with CRS. The study’s primary objective is to evaluate the efficacy of LYR-210, compared with a sham procedure, in improving the 3 cardinal symptoms of CRS, i.e., nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. Study subjects who receive the sham procedure will receive LYR-210 in the extension period.

Chronic rhinosinusitis (CRS) is a common condition defined by symptomatic inflammation of the paranasal sinuses lasting longer than 12 weeks. Common symptoms of CRS include nasal blockage/obstruction/congestion, facial pressure or pain, nasal discharge, and sense of smell dysfunction. The underlying cause of CRS-related symptoms is inflammation of mucosal tissue, often leading to impairment of mucociliary clearance.

The trial is being conducted at approximately 60 study sites in the US and Europe consisting of both private ENT clinics and academic medical centers. Dr. Ephrat and Lyra Therapeutics, Inc. are looking for individuals with CRS that meet these criteria:

• You are over 18 years of age
• You have documented medical history of CRS, and have not responded to at least 2 previous therapies, one of which must include intranasal corticosteroid sprays
• You have not had a previous ethmoidectomy surgery
• Other requirements apply

Patients with CRS who are interested in participating in LYR-210-2021-004 (ENLIGHTEN I) may visit https://www.clarahealth.com/studies/hearing-study to begin the application process.

About ENT and Allergy Associates, LLP:

ENT and Allergy Associates, LLP (ENTA) has over 240 physicians practicing in over 50 office locations in Westchester, Putnam, Orange, Dutchess, Rockland, Nassau and Suffolk counties, as well as New York City and northern/central New Jersey. The practice sees over 100,000 patients per month. Each ENTA clinical location provides access to a full complement of services, including General Adult and Pediatric ENT and Allergy, Voice and Swallowing, Advanced Sinus and Skull Base Surgery, Facial Plastics and Reconstructive Surgery, Disorders of the Inner Ear and Dizziness, Asthma, Clinical Immunology, Diagnostic Audiology, Hearing Aid dispensing, Sleep and CT Services. ENTA has clinical alliances with Cooperman Barnabas Medical Center, Mount Sinai Hospital, Montefiore Medical Center, Northwell Health, and a partnership with the American Cancer Society. To learn more, visit www.entandallergy.com.

 About Lyra Therapeutics, Inc.

Lyra Therapeutics, Inc. is a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, local delivery of medications to diseased tissues not accessible with conventional therapeutic approaches. Lyra’s XTreo™ platform is comprised of a biocompatible mesh scaffold, an engineered elastomeric matrix, and a versatile polymer-drug complex. The company’s current pipeline of therapeutics target tissues deep in the ear, nose, and throat passages and are designed to deliver continuous drug therapy for up to six months following a single non-invasive, in-office administration. Lyra has two product candidates in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities: LYR-210, for surgically naïve patients is being evaluated in the ENLIGHTEN Phase 3 clinical program, and LYR-220, is being evaluated in patients who have recurrent symptoms despite surgery in the BEACON Phase 2 clinical trial. These two product candidates are designed to treat the estimated four million CRS patients in the U.S. that fail medical management each year. For more information, please visit www.lyratherapeutics.com.

• Dr. Moshe Ephrat, MD, FACS