Lyra Therapeutics, Inc. announced that the first patients have been treated in Part 2, the randomized stage, of the Phase 2 BEACON clinical trial of LYR-220 in adult patients with chronic rhinosinusitis (CRS) who have had a prior sinus surgery. LYR-220 has been specifically designed to deliver six months of continuous anti-inflammatory medication in a controlled and consistent fashion to the sinonasal passages for the millions of CRS patients that continue to require treatment despite prior surgical treatment. The Phase 2 BEACON trial is a sham-controlled, parallel-group study to evaluate safety, tolerability, and pharmacokinetics of LYR-220 (7500µg MF) matrix, over a 24-week period, in symptomatic adult CRS patients who have had a prior bilateral sinus surgery.

Part 1 of the BEACON trial was uncontrolled and designed primarily to assess the feasibility and tolerability of two matrix designs. In the randomized Part 2 stage, one design of LYR-220 will be compared to control in approximately 40 patients. In the Part 1 stage, six patients received the LYR-220 matrix implant, 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 have been reported. Although efficacy evaluation is not the objective during the uncontrolled Part 1 stage of the trial, there was a mean improvement of 21 points (37%) from the baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) total score at 6 weeks. This is greater than twice the minimal clinically important difference of 8.9 points.

The first patient was dosed in Part 2, which is the randomized, controlled portion of the BEACON trial, evaluating the safety and efficacy of LYR-220. The Company anticipates completing enrollment for the full Phase 2 BEACON trial around year-end.