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Lyra Therapeutics Presents Clinical Data for LYR-210 for Treatment of Chronic Rhinosinusitis at the American Rhinologic Society Annual Meeting

Tags:   Phase 2   Phase 1  

Phase 1 study in patients with chronic rhinosinusitis demonstrated safety and tolerability after 24 weeks of continuous anti-inflammatory treatment with long-acting LYR-210

Patients achieved significant improvement in sinonasal outcome test after single administration of LYR-210

Results support advancement into global Phase 2 clinical study for chronic rhinosinusitis

Proprietary technology platform enables long-acting therapy and targeting deep into sinonasal tissues


WATERTOWN, Mass.--(BUSINESS WIRE)--Lyra Therapeutics, Inc., a clinical-stage biotechnology company developing medicines precisely designed to target ear, nose and throat (ENT) diseases, today announced the presentation of Phase 1 clinical data for the company’s lead therapeutic, LYR-210, for chronic rhinosinusitis (CRS), a debilitating disease caused by inflammation of the paranasal sinus tissues that affects approximately 27 million people, or 11% of the adult population in the U.S.1 The Phase 1 data for LYR-210 was selected for an oral presentation as a top fifteen abstract at the 64th Annual Meeting of the American Rhinologic Society, which took place October 5-6 in Atlanta.


In the Phase 1 study, CRS patients who have not had sinus surgery received in-office bilateral administration of LYR-210, deep into the sinonasal passages, designed to provide long-acting release of anti-inflammatory steroid through a proprietary, biodegradable polymeric matrix at the site of disease. Results from the Phase 1 study showed that LYR-210 was safe and well tolerated and the CRS patients achieved significant improvement in the sinonasal outcome test (SNOT-22) after single administration of LYR-210, which provided 24 weeks of continuous anti-inflammatory drug treatment. SNOT-22 is a symptom-based questionnaire that can be used to assess nasal obstruction and the impact of sinonasal disease. Results from the Phase 1 study support the advancement of LYR-210 into a Phase 2 study that is planned to begin in the first half of 2019.



“There is significant unmet medical need for new treatment options for patients with chronic rhinosinusitis which affects millions of patients in their daily lives. These results from the Phase 1 study show that LYR-210 offers a promising new front-line approach to deliver 24 weeks of continuous anti-inflammatory therapy to the tight anatomy of the sinonasal tissues and demonstrates rapid, clinically meaningful and durable results for patients with this debilitating disease,” said Richard Douglas, M.D., Professor of Surgery at The University of Auckland, New Zealand, and Consultant Surgeon at Auckland City Hospital and the lead investigator in the LYR-210 clinical study. “Based on these positive Phase 1 results in CRS patients, I am enthusiastic about future clinical studies with LYR-210 to further demonstrate its clinical value and advance this innovative therapy for patients.”


“We are very encouraged by the results of the Phase 1 study with LYR-210, which is the first time clinical data has been reported for a long-acting intranasal steroid therapeutic system in CRS patients who have not undergone previous endoscopic sinus surgery. Additionally, it is very promising that LYR-210 showed early efficacy results in CRS patients both with and without polyps. We believe these clinical results position LYR-210 with a highly differentiated product profile that offers six months of anti-inflammatory drug therapy with a single administration,” said Maria Palasis, Ph.D., President and Chief Executive Officer of Lyra Therapeutics. “Our team is focused on rapidly advancing LYR-210 into a Phase 2 study and progressing toward bringing a new treatment alternative to patients with CRS.”


At the Annual Meeting of the American Rhinologic Society, Dr. Richard Douglas delivered the oral presentation of the clinical results from the Phase 1 study of LYR-210 in chronic rhinosinusitis, including the following highlights:


About LYR-210

LYR-210 is the only product announced in clinical development for chronic rhinosinusitis (CRS) offering six months of drug therapy with a single administration. Utilizing Lyra’s proprietary transmucosal therapeutic system, LYR-210 is engineered to deliver a custom long-acting formulation of an approved steroid, mometasone furoate, deep into the sinonasal tissues that are not accessible with conventional therapeutic approaches. LYR-210 is biodegradable and is designed to be administered by a physician in an office setting.


About Lyra Therapeutics

Lyra Therapeutics is a clinical-stage biotechnology company developing medicines precisely designed to target ear, nose and throat (ENT) diseases, offering an alternative to conventional treatments or surgeries. The company’s lead drug candidate, LYR-210, offers a novel approach for directing anti-inflammatory medicine deep into sinonasal tissues for up to six months of therapy. With proprietary expertise in drug development and materials science, Lyra is applying its transmucosal therapeutic system – comprised of drug administered through a polymeric matrix – with the goal of enabling therapeutic action at the site of inflammation in the sinonasal passages. Lyra Therapeutics is located in Watertown, Massachusetts. For more information, please visit www.lyratx.com.



1 U.S. Centers for Disease Control, https://www.cdc.gov/nchs/fastats/sinuses.htm


Contacts

For Lyra TherapeuticsKathryn MorrisTel: 914-204-6412kathryn@theyatesnetwork.com


For Lyra TherapeuticsKathryn MorrisTel: 914-204-6412kathryn@theyatesnetwork.com