On February 6, 2023, Lyra Therapeutics, Inc., a leading clinical-stage biotechnology firm developing novel therapies for the localized treatment of chronic rhinosinusitis (CRS), announced that enrollment in the Phase 2 BEACON clinical trial of LYR-220 in adult patients with CRS who have previously undergone sinus surgery has been completed.
LYR-220 is designed to provide continuous anti-inflammatory medicine (mometasone furoate; MF) to the sinonasal passageways for six months in order to treat CRS. Topline outcomes are expected in the fourth quarter of 2023.
The Phase 2 BEACON trial is a sham-controlled, parallel-group trial designed to assess the efficacy and safety of the LYR-220 (7500g MF) matrix in symptomatic adult CRS patients who have previously had bilateral ethmoid sinus surgery during a 24-week period. The trial is divided into two parts: Part 1 was aimed to examine the feasibility and tolerability of two 7500µg MF matrix designs; in Part 2, 40 patients were randomly assigned 1:1 to receive LYR-220 or sham control.
Lyra revealed positive preliminary findings from the BEACON trial's Part 1, the non-randomized portion, in September 2022, indicating the feasibility and tolerability of bilateral LYR-220 placement in this patient population. In addition, all six patients were given the medication for at least six weeks, and no significant or unexpected side effects were recorded.
Although efficacy evaluation was not the goal of the trial's uncontrolled Part 1 stage, there was a mean improvement of 21 points (37%) from baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) total score at six weeks. This is more than double the minimal clinically significant difference of 8.9 points.
About Lyra Therapeutics
Founded in 2018, Lyra Therapeutics is a clinical-stage firm pioneering a novel therapeutic approach for the treatment of debilitating ear, nose, and throat (ENT) diseases that affect millions of people. Its mission is to change the ENT treatment paradigm by giving physicians effective front-line solutions and innovative therapy alternatives for their patients. The company is working on therapeutics for the localized treatment of chronic rhinosinusitis patients (CRS). Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stage development for CRS, which is a common inflammatory disease of the paranasal sinuses that causes debilitating symptoms and significant morbidities. It is headquartered in the Boston region and was created by academic luminaries in the disciplines of chemistry, materials science, and biotechnology, and is supported by top life science investors.