Lyra Therapeutics, Inc. today announced that the first patient was treated in the Part 1/non-randomized portion 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 is 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 a prior surgery. Topline results from Part 1 of the Phase 2 BEACON trial are expected around year end.
“We have limited and often ineffective treatment options to alleviate persistent, burdensome symptoms in CRS patients that have been previously operated on,” said Anders Cervin, MD, PhD, Professor Chair in Otolaryngology at the Centre for Clinical Research, Royal Brisbane & Women’s Hospital Campus, Herston, in Queensland, Australia, and Principal Investigator in the BEACON study. “LYR-220 could represent a meaningful advance in care for these underserved patients, the majority of whom have no approved drug treatment options.”
The Phase 2 BEACON trial is a controlled parallel-group study to evaluate safety, tolerability, pharmacokinetics, and efficacy comparing two designs of the LYR-220 (7500µg MF) matrix to control, over a 24-week period, in approximately 70 symptomatic adult CRS subjects who have had a prior bilateral sinus surgery. Part 1 is a non-randomized, open-label study assessing the feasibility of placement optimizing the procedure, while Part 2 will be a patient-blinded, 1:1:1 randomized assessment of two designs versus sham control. The Company anticipates completing enrollment for the full Phase 2 BEACON trial around year end.
“This represents a significant milestone for Lyra as we advance our second CRS product candidate into late-stage development, positioning us to potentially be the first to offer solutions for the full spectrum of CRS patients treated by ENT physicians,” said Maria Palasis, PhD, President and Chief Executive Officer of Lyra Therapeutics. “We look forward to advancing LYR-220 through the clinic and leveraging the path of LYR-210, our investigational therapy for CRS patients with surgically-naïve anatomy, currently in a pivotal Phase 3 trial (ENLIGHTEN I), for future regulatory filings.”