Lyra Therapeutics has treated the first subject in the Part one/non-randomised portion of the Phase II BEACON clinical trial of its investigational product candidate, LYR-220, in adults with post-surgical chronic rhinosinusitis (CRS).
Leveraging the XTreo platform of the company, LYR-220 is a bioresorbable polymeric matrix.
LYR-220 is intended to offer up to six months of continuous local, intra-nasal, anti-inflammatory mometasone furoate drug therapy to the sinonasal passages of CRS patients who had a sinus surgery.
For CRS patients with enlarged nasal cavity as a result of sinus surgery but still need medication to control CRS symptoms, LYR-220 offers a non-invasive substitute to repeated sinus surgery.
The company anticipates topline data from Part one of the BEACON trial by the end of this year.
The controlled, parallel-group trial will analyse the safety, tolerability, pharmacokinetics and efficacy comparing two designs of LYR-220 (7500µg MF) to control for 24 weeks in nearly 70 symptomatic adult CRS patients who had a bilateral sinus surgery.
A non-randomised, open-label study, Part one of the trial will analyse the feasibility of placement enhancing the procedure while Part two will be a patient-blinded, 1:1:1 randomised assessment of two designs compared to sham control.
The company plans to conclude subject enrolment for the full BEACON trial by this year end.
Lyra Therapeutics president and CEO Maria Palasis said: “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.
“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 III trial (ENLIGHTEN I), for future regulatory filings.”