Lyra Therapeutics Completes Enrollment for Phase 3 ENLIGHTEN 2 Trial of LYR-210 for Chronic Rhinosinusitis

Topline Results Expected Q2 2025

WATERTOWN, Mass., Oct. 15, 2024 – Lyra Therapeutics, Inc. (Nasdaq: LYRA), a biotechnology firm in the clinical stage, is advancing long-term anti-inflammatory treatments for chronic rhinosinusitis (CRS). The company has recently announced the full enrollment of their pivotal Phase 3 ENLIGHTEN 2 clinical trial for LYR-210, targeting adult CRS patients who have not undergone prior ethmoid sinus surgery. LYR-210 is a nasal implant that is bioresorbable and designed to provide six months of continuous anti-inflammatory medication using mometasone furoate for CRS treatment. The topline results from this study are anticipated in the second quarter of 2025.

Dr. Maria Palasis, President and CEO of Lyra Therapeutics, expressed satisfaction with the milestone, acknowledging the efforts of both participants and investigators involved in the ENLIGHTEN trials. She emphasized the potential benefits that the company's technology could offer to CRS patients.

The ENLIGHTEN program comprises two pivotal Phase 3 clinical trials, ENLIGHTEN 1 and ENLIGHTEN 2, which assess the safety and effectiveness of LYR-210 in treating CRS. Each trial has around 180 participants who have not responded to medical treatment and have not had prior ethmoid sinus surgery. Participants were randomized in a 2:1 ratio to receive either LYR-210 (7500µg mometasone furoate) or a sham control for a duration of 24 weeks.

LYR-210 is an investigational product aimed at CRS patients who have not had success with existing therapies and need additional intervention. This nasal implant, which can be inserted through a simple procedure in a doctor's office, is intended to deliver continuous anti-inflammatory therapy for six months to the sinonasal passages using mometasone furoate. It is currently under evaluation in the ENLIGHTEN pivotal Phase 3 clinical program.

Lyra Therapeutics, Inc. is focused on developing long-acting anti-inflammatory implants for sinonasal treatment, specifically for CRS. The company addresses CRS, an inflammatory disease of the paranasal sinuses that is both widespread and debilitating. Their lead product, LYR-210, is a bioabsorbable implant meant to be administered in a straightforward, in-office procedure. It aims to deliver a six-month continuous anti-inflammatory drug therapy (7500µg mometasone furoate) to the sinonasal passages with just one administration. LYR-210 is part of their ENLIGHTEN Phase 3 clinical program and is designed for patients with typical anatomical structures, particularly those who have not had ethmoid sinus surgery. Lyra Therapeutics aims to treat the approximately four million CRS patients in the United States who do not respond to medical management each year.