Lyra Therapeutics (NASDAQ:LYRA) resumed screening and enrollment in ENLIGHTEN II, its second Phase 3 clinical trial of LYR-210 in patients with chronic rhinosinusitis (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 the first half of 2024. Lyra announced in November 2022 that it temporarily paused enrollment in ENLIGHTEN II due to a transition to in-house manufacturing to ensure consistent clinical supply of LYR-210.
The company expects to complete enrollment in the ENLIGHTEN II trial in the second half of 2024. Lyra is manufacturing LYR-210 in house for both ENLIGHTEN trials.
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 or control.
