Lyra Therapeutics Announces Publication of Preclinical Pharmacokinetics and Drug Release characterization for XTreo™ Technology Platform
Lyra Therapeutics Announces Publication of Preclinical Pharmacokinetics and Drug Release characterization for XTreo™ Technology Platform in the American Journal of Rhinology & Allergy
Lyra Therapeutics, Inc., a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, and local delivery of medications to the ear, nose and throat (ENT) passages and other diseased tissues, today announced that preclinical data for XTreo™ were published online in the peer-review journal, American Journal of Rhinology & Allergy. The manuscript titled, “Drug Release and Pharmacokinetic Evaluation of Novel Implantable Mometasone Furoate Matrices in Rabbit Maxillary Sinuses,” can be accessed online here.
The pharmacokinetics and drug release study evaluated the release of mometasone furoate (MF), a potent anti-inflammatory corticosteroid formulated into Lyra’s proprietary XTreo™ matrix, in a rabbit model. The results demonstrate that XTreo™ MF provides targeted, sustained and efficient dosing to local sinus tissues that is superior to intranasal corticosteroid sprays (INCS). LYR-210 and LYR-220, Lyra’s product candidates, are built upon the XTreo™ platform and are currently in late-stage clinical development for the treatment for chronic rhinosinusitis (CRS).
“The outcomes from this study supported Lyra’s advancement into clinical development for the first application of our novel XTreo™ platform, LYR-210 for the treatment of Chronic Rhinosinusitis (CRS), which is now poised to enter Phase 3 studies,” said Maria Palasis, Lyra’s President and Chief Executive Officer. “XTreo™ is a powerful drug delivery platform that can target a precise dose of a therapeutic agent consistently over an extended period of time, up to many months. These characteristics translate into multiple potential benefits, including increased efficacy, elimination of patient adherence issues, and avoidance of systemic side effects. We believe our proprietary platform technology can provide optimal treatment for CRS, as well as other chronic ear, nose and throat (ENT) diseases.”
Lyra’s XTreo™ technology platform enables precise, sustained, local delivery of medications to diseased tissues not accessible with conventional therapeutic approaches. The XTreo™ matrix is a tubular elastomeric mesh comprised of biocompatible and bioresorbable materials that can be formulated for delivery of a range of therapeutic agents directly to targeted tissues, with a single administration.
Study Results
The study evaluated the in vitro drug release and in vivo pharmacokinetics of novel XTreo™ MF matrices in a rabbit dorsal maxillary osteotomy model. The matrices were formulated to consistently elute MF for up to 6 months and were surgically placed bilaterally into the maxillary sinuses of New Zealand White (NZW) rabbits. Tissue and plasma MF concentrations were measured to assess the in vivo drug delivery. The in vivo and in vitro drug release kinetics of the matrices were quantified and compared to those of rabbits receiving daily Nasonex® MF nasal sprays. Key findings include:
- XTreo™ matrices self-expanded upon deployment to conform to the irregular geometry of the maxillary sinus cavities in the NZW rabbits.
- Sustained release of MF was demonstrated in vitro and in vivo for 2 MF matrices of distinct release durations and an in vitro–in vivo correlation was established.
- Therapeutic levels of MF in local tissues were measured throughout the intended dosing durations. In contrast to the variable peaks and troughs of daily nasal sprays, sustained dosing via a single administration of MF matrices was confirmed by quantifiable plasma MF concentrations over the intended dosing duration.
- Low levels of MF were detected in plasma, demonstrating that the XTreo™ matrix can maximize the therapeutic effect to the immediately contacted tissues while potentially eliminating systemic side effects.
About LYR-210 for Chronic Rhinosinusitis
LYR-210 is an investigational product candidate that utilizes Lyra’s proprietary XTreo™ platform to enable six months of local, intra-nasal, anti-inflammatory therapy from a single administration for chronic rhinosinusitis (CRS). LYR-210 is designed as a non-invasive alternative to sinus surgery for the millions of CRS patients who have failed medical management. It is a bioresorbable polymeric matrix administered in a brief, non-invasive, in-office procedure and is intended to deliver up to six months of continuous mometasone furoate drug therapy to the sinonasal passages. In the LANTERN Phase 2 study, LYR-210 (7500mcg) demonstrated rapid, clinically meaningful and durable symptom improvement as measured by the SNOT-22 score and a cardinal symptom score over six months. There are approximately 14 million patients with CRS in the US, approximately 4 million of whom fail current standard of care medical management.
About Lyra Therapeutics
Lyra Therapeutics, Inc. is a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, local delivery of medications to diseased tissues not accessible with conventional therapeutic approaches. Lyra’s XTreo™ platform is comprised of a biocompatible mesh scaffold, an engineered elastomeric matrix and a versatile polymer-drug complex. The company’s current pipeline of therapeutics target tissues deep in the ear, nose and throat passages and are designed to deliver continuous drug therapy for up to six months following a single non-invasive, in-office administration. Lyra’s lead product candidate, LYR-210, is entering Phase 3 clinical development for the treatment of chronic rhinosinusitis (CRS) as an alternative to primary sinus surgery. Lyra’s second product candidate, LYR-220, is entering Phase 2 development and is designed to be an alternative to revision CRS sinus surgery and post-surgical medical management. For more information, please visit www.lyratherapeutics.com and follow us on LinkedIn and Twitter.