Lyra Therapeutics Fully Enrolls Pivotal Phase 3 ENLIGHTEN I Trial of LYR-210 for the Treatment of Chronic Rhinosinusitis

Topline Results Expected 1H 2024

WATERTOWN, Mass., Aug. 29, 2023 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting anti-inflammatory therapies for the localized treatment of chronic rhinosinusitis (CRS), today announced that the pivotal Phase 3 ENLIGHTEN I clinical trial of LYR-210 in adult patients with CRS who have not had prior ethmoid sinus surgery, is fully enrolled. LYR-210 is a bioresorbable nasal implant designed to deliver six months of continuous anti-inflammatory medication (mometasone furoate; MF) to the sinonasal passages for the treatment of CRS. Topline results from ENLIGHTEN I are expected in the first half of 2024 as planned.

“We are pleased to have fully enrolled the first of our two pivotal trials of LYR-210 in CRS patients,” said Richard Nieman, MD, Chief Medical Officer of Lyra Therapeutics. “Our clinical team is now focusing all of its recruitment efforts on the second of our two pivotal trials, ENLIGHTEN II, for which we expect to complete enrollment in the second half of 2024,” Dr. Nieman continued. “We thank the participants and the investigators in the ENLIGHTEN studies as we advance our technology that could potentially benefit millions of patients with CRS.”

About the ENLIGHTEN Pivotal Program

The ENLIGHTEN program consists of two pivotal Phase 3 clinical trials, ENLIGHTEN I and ENLIGHTEN II, to evaluate the efficacy and safety of LYR-210 for the treatment of CRS. Each ENLIGHTEN trial is enrolling 180 CRS patients who have failed medical management and have not had prior ethmoid sinus surgery, randomized 2:1 to either LYR-210 (7500µg mometasone furoate (MF)) or sham control for 24 weeks. The two pivotal trials will support a New Drug Application to the U.S. Food and Drug Administration for LYR-210. Lyra has manufactured clinical supply of LYR-210 in house for both ENLIGHTEN trials.

About LYR-210

LYR-210 is an investigational product candidate for the treatment of chronic rhinosinusitis (CRS) in patients who have failed current therapies and require further intervention. LYR-210 is a bioresorbable nasal implant designed to be inserted in a simple, in-office procedure. LYR-210 is intended to deliver six months of continuous anti-inflammatory therapy, mometasone furoate, to the sinonasal passages to treat CRS. In the LANTERN Phase 2 randomized, controlled trial of LYR-210 for the treatment of CRS, LYR-210 achieved rapid and durable improvements in the SinoNasal Outcome Test (SNOT-22) score over 24 weeks. No treatment-related Serious Adverse Events (SAEs) were observed. LYR-210 is being evaluated in the ENLIGHTEN Phase 3 pivotal clinical program.