Lyra Therapeutics Announces Publication of Positive LANTERN Results in the International Forum of Allergy & Rhinology

Company to Initiate Phase 3 ENLIGHTEN Program around YE’21

Lyra Therapeutics, Inc. (Nasdaq: LYRA), 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 the positive results of the Company’s Phase 2 LANTERN study of LYR-210 were published online in the peer-review journal, International Forum of Allergy & Rhinology. The manuscript titled, “Long-acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase 2 randomized controlled study,” can be accessed online here.

The LANTERN study evaluated the safety and efficacy of LYR-210 in surgically naïve CRS patients who had failed previous medical management. LYR-210 (7500 µg) was shown to be safe and well-tolerated over the 24-week treatment period and demonstrated statistically significant, rapid, durable, dose-dependent global symptom improvement based on composite Cardinal Symptoms (CS) scores and Sino-Nasal Outcome Test (SNOT-22).

“LYR-210 is the first and only CRS treatment candidate for surgically naïve CRS patients to demonstrate statistically significant and clinically meaningful global symptom improvement based on SNOT-22, the most widely used tool for the measurement of sinonasal symptoms, with results sustained for six months from a single, non-invasive, in-office administration,” said Robert Kern, MD, Chief Medical Officer of Lyra Therapeutics. “With 4 million patients failing medical management annually, chronic rhinosinusitis is described in the literature as an ‘unrecognized epidemic’ due to its high prevalence, substantial impact on patient quality of life, and significant limitations of treatment options.1 ENTs are eager for new options to help their CRS patients who have failed medical management but want to avoid surgery. I believe that LYR-210 has the potential to completely transform the CRS treatment paradigm.”

“LYR-210 is built upon Lyra’s proprietary XTreo™ platform, which delivers the right drug to the right place for the right amount of time. By delivering a consistent daily dose of the anti-inflammatory medication mometasone furoate directly to the sinonasal tissues continuously for six months, LYR-210 has shown robust CRS symptom improvement. Our upcoming Phase 3 ENLIGHTEN program will be designed to further demonstrate LYR-210’s potential to provide a meaningful improvement in the lives of the millions of CRS patients, especially those without polyps who currently have no approved treatment options,” said Maria Palasis, PhD, President and Chief Executive Officer of Lyra Therapeutics.

LANTERN Study Results

The Phase 2, multicenter, blinded, randomized, controlled, dose-ranging study evaluated the safety and efficacy of LYR-210 (2500 µg) and LYR-210 (7500 µg) in 67 surgically naïve adult CRS patients who had failed previous medical management. Both LYR-210 doses were safe and well-tolerated over the 24-week treatment period. LYR-210 (7500 μg) demonstrated rapid, durable, dose-dependent, global symptom improvement, achieving statistical significance as early as 8 weeks and out to 24 weeks compared with control. Key results include:

• Rapid, durable and clinically meaningful symptom improvement by SNOT-22Statistically significant improvement of composites of 3 and 4 Cardinal Symptoms (nasal blockage, facial pain/pressure, nasal discharge, olfactory loss - 4 only) at 24 weeks
  • Greater than 2-fold the MCID of 8.9 points relative to control at 24 weeks
  • 70% of patients in the 7500 µg group improved MCID at week 4; 100% by week 24
• 24-week benefit from a single administration
• Showed benefit in both polyp and non-polyp patients
• Reduced rescue treatment use and radiographic ethmoid opacification at week 24

About LYR-210 for Chronic Rhinosinusitis

LYR-210 is an investigational product candidate that utilizes Lyra’s proprietary XTreoTM 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.