Lyra Therapeutics, Inc. announced completion of enrollment in the Phase 2 BEACON clinical trial of LYR-220 in adult patients with CRS who have had prior sinus surgery. LYR-220 is designed to deliver six months of continuous anti-inflammatory medication (mometasone furoate; MF) to the sinonasal passages for the treatment of CRS. Topline results are expected in the fourth quarter of 2023.

The Phase 2 BEACON trial is a sham-controlled, parallel-group study to evaluate safety and efficacy of the LYR-220 (7500µg MF) matrix, over a 24-week period, in symptomatic adult CRS patients who have had a prior bilateral ethmoid sinus surgery. The trial consists of two parts: Part 1 was designed primarily to assess the feasibility and tolerability of two 7500µg MF matrix designs; in Part 2, 40 patients have been randomized 1:1 to receive LYR-220 or sham control. In September 2022, Lyra announced positive initial data from the Part 1, non-randomized portion of the BEACON trial, demonstrating the feasibility and tolerability of LYR-220 placement bilaterally in this patient population.

All six patients were treated for at least six weeks and no serious or unexpected product-related adverse events were reported. Although efficacy evaluation was not the objective in the uncontrolled Part 1 stage of the trial, 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 greater than twice the minimal clinically important difference of 8.9 points.