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. 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:
- The Phase 1 study enrolled 20 patients with moderate to severe CRS who failed standard medical management and were candidates for endoscopic sinus surgery, but had not undergone previous endoscopic sinus surgery. CRS patients with and without polyps were enrolled in the study.
- All patients were administered long-acting LYR-210 in the outpatient setting of an ENT physician's office. In the study, LYR-210 had a 100 percent success rate for bilateral placement of the LYR-210 transmucosal therapeutic system in the sinonasal passages.
- Safety was the primary objective of the Phase 1 study, and LYR-210 was safe and well-tolerated with no product-related serious adverse events reported in the study.
- In the overall study population, subjects experienced clinically meaningful, statistically significant improvement from baseline in their SNOT-22 scores (P < 0.01), and improvement was observed as early as week 1 and persisted through week 24. Significant symptom improvement was also achieved in the SNOT-22 rhinological, ear-facial, psychological, and sleep dysfunction subdomains, through week 24.
- In the study, no topical nasal spray was utilized in conjunction with LYR-210. No patients required surgical intervention during the 24-week treatment period.
- LYR-210 successfully demonstrated the design parameters of the transmucosal therapeutic system - comprised of drug administered through a biodegradable polymeric matrix - by delivering a custom long-acting formulation of the approved steroid, mometasone furoate, deep into the sinonasal tissues to provide anti-inflammatory therapy for six months.