Lyra Therapeutics Announces Positive Topline Results of Pharmacokinetic Study of LYR-210 in Patients With Chronic Rhinosinusitis
Lyra Therapeutics, Inc. recently announced positive topline results from the company’s pharmacokinetic (PK) study of LYR-210. Data obtained from the study are supportive of LYR-210’s safety profile and provide a PK bridge to the established safety of mometasone furoate (MF) for a 505(b)(2) pathway for New Drug Approval (NDA) submission.
The clinical study was a 56-day open label, multi-center, US study of the PK and safety of LYR-210 in adult subjects with chronic rhinosinusitis (CRS). The primary objective of the study was to establish the PK profile of LYR-210. The study enrolled 24 patients, half of whom received LYR-210 2500 µg and the other half received LYR-210 7500 µg. The study indicated that both doses were safe and well tolerated, with the mean maximum plasma concentration (Cmax) observed with the 7500 µg dose well below Cmax established for US FDA-approved formulations of MF. MF blood plasma levels observed during the PK study support LYR-210’s ability to deliver consistent and steady dosing over the entire treatment period. This was the first US study of LYR-210 and it was fully enrolled across four sites in 11 weeks.
“The data from our PK study suggests that LYR-210 can elute mometasone furoate safely, consistently for 6 months, and locally to the inflamed mucosal tissue of CRS patients,” said Maria Palasis, PhD, President and Chief Executive Officer of Lyra Therapeutics. “These results will support a 505(b)(2) pathway for LYR-210’s NDA submission. We are delighted at the rapid pace of enrollment of our first US patients, and believe this bodes well for interest at US sites for our Phase 3 program, which we expect to initiate around the end of the year.”
“LYR-210 is highly convenient to implant and explant in a routine office visit and seamlessly conforms to the patient’s nasal anatomy that enables continuous treatment for up to 6 months with one application,” said Randall Ow, MD, FACS, FARS, FAAOA, FAPCR, of Sacramento Ear Nose & Throat, and an investigator in the PK study. “LYR-210 has the potential to address a broad patient population and could provide a meaningful treatment option to CRS patients who fail medical management.”
Lyra will present the data from its PK study of LYR-210 during a podium presentation at the upcoming American Rhinologic Society Annual meeting in October 2021.
LYR-210 is an investigational product candidate that utilizes Lyra’s proprietary XTreo platform to enable 6 months of local, intra-nasal, anti-inflammatory therapy from a single treatment 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 designed to be 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 (7500 µg) demonstrated rapid, clinically meaningful and durable symptom improvement in CRS three cardinal symptoms (3CS) over 6 months. There are approximately 14 million patients with CRS in the US, approximately 4 million of whom fail current standard of care medical management.
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 months following a single non-invasive, in-office administration. Lyra’s lead product candidate, LYR-210, is in late-stage clinical development for the treatment of chronic rhinosinusitis and is designed to deliver up to 6 months of continuous anti-inflammatory drug therapy to the sinonasal passages. For more information, visit www.lyratherapeutics.com.
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