Lyra Therapeutics announced the U.S. FDA has cleared the company’s Investigational New Drug (IND) application for LYR-210 for the treatment of chronic rhinosinusitis (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.
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. 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.
LYR-210 met its primary safety endpoint in a phase 1 trial, and it was observed that patients generally experienced significant and rapid, clinically meaningful and durable improvement in SNOT-22 scores, an established patient symptom severity scale, through week 25, which was the end of the trial.
The therapeutic embedded within LYR-210 is mometasone furoate, which is the active ingredient in various FDA-approved drugs and has a well-established efficacy and safety profile. LYR-210 designed to provide up to six months of drug therapy in a single administration for chronic rhinosinusitis. The company is advancing LYR-210 as a potential preferred alternative to surgery.
CRS is an inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities and affects approximately 13 million people in the United States.