Lyra Therapeutics, Inc. announced that it has resumed screening and enrollment in ENLIGHTEN II, its second pivotal Phase 3 clinical trial of LYR-210 in patients with CRS. LYR-210 is a bioresorbable nasal implant designed as an alternative to sinus surgery for the millions of CRS patients who remain symptomatic despite treatment. 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.

Enrollment in the ENLIGHTEN I clinical trial remains on track, with pivotal data anticipated in 1H 2024. Lyra announced in November 2022 that it temporarily paused enrollment in ENLIGHTEN I due to a transition to in-house manufacturing to ensure consistent clinical supply of LYR-210. 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 (7500ug mometasone furoate (MF)) or control.

Together, the two pivotal trials are expected to support an anticipated New Drug Application to the U.S. Food and Drug Administration for LYR-210. LYR-210 is an investigational product candidate for use in chronic rhinosinusitis (CRS) patients who have failed current treatments and require further intervention. LYR-210 is designed for surgically naive patients and is being evaluated in the ENLIGHTEN Phase 3 clinical program, while LYR-220, an enlarged implant, is being evaluated in the BEACON Phase 2 clinical trial in patients who have recurrent symptoms despite having had prior ethmoid sinUS surgery.