Lyra Therapeutics has enrolled the first subject in the Phase III ENLIGHTEN II clinical trial to evaluate its investigational product candidate, LYR-210, in adults with chronic rhinosinusitis (CRS).
The multi-centre, randomised, controlled ENLIGHTEN II is the second Phase III study in the pivotal clinical programme for the therapy, along with the ENLIGHTEN I trial that commenced earlier this year.
These two trials will enrol CRS patients, who are surgically naïve, in Europe and the US.
They will support the submission of a New Drug Application for LYR-210 to the US Food and Drug Administration.
Lyra Therapeutics president and CEO Maria Palasis said: “We are excited about the ENLIGHTEN pivotal programme, with both Phase III trials now actively enrolling patients.
“LYR-210 is the first CRS product candidate designed to provide six months of continuous therapy with a single treatment, and we are focused on the opportunity to bring a new standard of care to the millions of CRS patients suffering with the disease.”
The ENLIGHTEN clinical programme comprises two Phase III studies which are expected to enrol a total of 360 adult, surgically-naïve CRS patients.
The ENLIGHTEN II trial is designed for assessing the safety and efficacy of LYR-210 (7500µg MF) compared to the control.
It will enrol nearly 180 CRS patients who have failed medical management and did not have sinus surgery previously.
These patients will be randomised into a 2:1 ratio to either LYR-210 (7500µg MF) or the control.
Variation from baseline in a composite score of three cardinal symptoms (3CS) of CRS at week 24 is the trial’s primary endpoint.
LYR-210 has been designed as a non-invasive alternative to sinus surgery for CRS patients who remain symptomatic, even after treatment.
In April this year, Lyra Therapeutics treated the first subject in the Part one/non-randomised portion of the Phase II BEACON clinical trial of LYR-220 in adults with post-surgical chronic rhinosinusitis.