Lyra Therapeutics, Inc., a clinical-stage therapeutics company focused on the development and commercialization of novel integrated drug and delivery solutions for the localized treatment of patients with ear, nose and throat diseases, has announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for LYR-210 for the treatment of chronic rhinosinusitis (CRS), a debilitating chronic disease affecting millions of patients.
LYR-210 is the company’s lead product candidate that is designed to deliver continuous drug therapy to the sinonasal passages for up to six months with a single administration for the treatment of CRS. Lyra plans to incorporate U.S. clinical sites into LANTERN, its ongoing global Phase 2 clinical trial of LYR-210, which was initiated in May 2019 at sites in New Zealand, Australia and Europe.
“We believe that FDA clearance of our IND for LYR-210 is a significant milestone in our global clinical program for CRS,” said Maria Palasis, Ph.D., President and Chief Executive Officer of Lyra Therapeutics. “We look forward to continuing our progress and expanding the geography of our LANTERN study with LYR-210, as we seek to advance a new treatment paradigm for patients with this debilitating disease.”
The Phase 2 LANTERN study is an ongoing randomized, sham procedure-controlled, patient-blinded clinical trial to evaluate the safety and efficacy of LYR-210 in adult patients with CRS with and without nasal polyps. In the Phase 2 LANTERN study, CRS patients who have not had sinus surgery will receive in-office bilateral administration of either one of two dose levels of LYR-210 or a sham procedure. LYR-210 is designed to be administered into the sinonasal passages through a single-use applicator and to deliver drug locally at the site of inflammation as a potential preferred alternative to surgery for patients who have failed medical management.