Lyra Therapeutics has restarted screening and enrolment of patients in its second pivotal Phase III clinical trial, ENLIGHTEN II, of LYR-210 for the treatment of chronic rhinosinusitis (CRS).

A bioresorbable nasal implant, LYR-210 is designed as an alternative to sinus surgery for CRS patients who remain symptomatic although treated.

It delivers an anti-inflammatory therapy, mometasone furoate, to the sinonasal passages continuously for up to six months and treats CRS.

ENLIGHTEN II is a part of Lyra’s ENLIGHTEN programme including ENLIGHTEN I study, whose enrolment is ongoing.

Each ENLIGHTEN trial will enrol 180 CRS patients who have failed medical management and have not had prior ethmoid sinus surgery.

Patients will be randomised in a 2:1 fashion to either receive LYR-210 (7500µg mometasone furoate (MF)) against a control.

Lyra president and CEO Maria Palasis said: “Our in-house manufacturing team was able to expedite the increased production of LYR-210 to allow us to resume enrollment in ENLIGHTEN II ahead of our original expectation of third quarter of 2023.

“We believe that Lyra’s internal manufacturing capabilities and quality systems will continue to strengthen our ability to expedite our promising candidates toward approval and commercialization, while reducing regulatory risk and risks associated with technology transfer to third parties.”

ENLIGHTEN II trial’s enrolment is expected to be completed in the second half of 2024, while the pivotal data of ENLIGHTEN I is anticipated in first half of 2024.

The two pivotal trials’ data of LYR-210 will be used to support an anticipated new drug application to the US Food and Drug Administration.