Lyra Therapeutics Fully Enrolls Pivotal Phase 3 ENLIGHTEN 2 Trial of LYR-210 for the Treatment of Chronic Rhinosinusitis
Lyra Therapeutics (Nasdaq: LYRA) has announced full enrollment for its pivotal Phase 3 ENLIGHTEN 2 clinical trial of LYR-210, a treatment for chronic rhinosinusitis (CRS) in adult patients without prior ethmoid sinus surgery. LYR-210 is a bioresorbable nasal implant designed to deliver six months of continuous anti-inflammatory medication (mometasone furoate) to sinonasal passages.
The company expects to report topline results in Q2 2025. This trial is the second of two pivotal studies for LYR-210 in CRS patients. Dr. Maria Palasis, President and CEO of Lyra Therapeutics, expressed gratitude to the participants and investigators involved in the ENLIGHTEN studies, emphasizing the potential benefit of their technology for CRS patients.
Lyra Therapeutics (Nasdaq: LYRA) ha annunciato il completamento dell'arruolamento per il suo studio clinico pivotale di Fase 3 ENLIGHTEN 2 per LYR-210, un trattamento per la rinosinusite cronica (CRS) in pazienti adulti senza precedenti interventi chirurgici ai seni etmoidei. LYR-210 è un impianto nasale bioassorbibile progettato per somministrare sei mesi di terapia continua anti-infiammatoria (furoato di mometasone) nelle vie sinonasali.
L'azienda prevede di riportare i risultati principali nel Q2 2025. Questo studio è il secondo di due studi pivotal per LYR-210 in pazienti con CRS. La Dr.ssa Maria Palasis, Presidente e CEO di Lyra Therapeutics, ha espresso gratitudine ai partecipanti e agli investigatori coinvolti negli studi ENLIGHTEN, sottolineando il potenziale beneficio della loro tecnologia per i pazienti con CRS.
Lyra Therapeutics (Nasdaq: LYRA) ha anunciado la finalización de la inscripción para su estudio clínico pivotal de Fase 3 ENLIGHTEN 2 del LYR-210, un tratamiento para la rinosinusitis crónica (CRS) en pacientes adultos sin cirugía previa de seno etmoides. LYR-210 es un implante nasal bioabsorbible diseñado para proporcionar seis meses de medicamento antiinflamatorio continuo (furoato de mometasona) a los pasajes sinonasales.
La empresa espera informar los resultados preliminares en el Q2 de 2025. Este ensayo es el segundo de dos estudios pivotal para LYR-210 en pacientes con CRS. La Dra. Maria Palasis, Presidenta y CEO de Lyra Therapeutics, expresó su agradecimiento a los participantes e investigadores involucrados en los estudios ENLIGHTEN, enfatizando el potencial beneficio de su tecnología para los pacientes con CRS.
Lyra Therapeutics (Nasdaq: LYRA)가 성인 CRS(만성 비부비동염) 환자를 위한 치료제 LYR-210의 핵심 3상 ENLIGHTEN 2 임상 시험의 전체 등록을 완료했다고 발표했습니다. LYR-210은 생분해성 비강 이식편으로, 비부비동 통로에 6개월 동안 지속적인 항염증 약물(모메타손 푸로에이트)을 전달하도록 설계되었습니다.
회사는 2025년 2분기에 주요 결과를 발표할 예정이다. 이 시험은 CRS 환자를 위한 LYR-210의 두 개의 중요한 연구 중 두 번째입니다. Lyra Therapeutics의 CEO이자 회장인 Maria Palasis 박사는 ENLIGHTEN 연구에 참여한 참가자와 연구자에게 감사를 표하며 CRS 환자에게 이 기술이 줄 수 있는 잠재적 이점을 강조했습니다.
Lyra Therapeutics (Nasdaq: LYRA) a annoncé l'inscription complète pour son essai clinique pivot de Phase 3 ENLIGHTEN 2 concernant LYR-210, un traitement de la rhinosinusite chronique (CRS) chez les patients adultes sans chirurgie antérieure des sinus ethmoïdaux. LYR-210 est un implant nasal bioresorbable conçu pour délivrer six mois de médicaments anti-inflammatoires (furoate de mométasone) de manière continue aux passages sinonasaux.
L'entreprise prévoit de communiquer les résultats préliminaires au Q2 2025. Cet essai est le deuxième de deux études pivots pour LYR-210 chez les patients CRS. Dr Maria Palasis, présidente et PDG de Lyra Therapeutics, a exprimé sa gratitude aux participants et aux chercheurs impliqués dans les études ENLIGHTEN, soulignant le bénéfice potentiel de leur technologie pour les patients atteints de CRS.
Lyra Therapeutics (Nasdaq: LYRA) hat die vollständige Rekrutierung für seine entscheidende Phase-3-Studie ENLIGHTEN 2 zu LYR-210 bekannt gegeben, einer Behandlung für chronische Nasennebenhöhlenentzündung (CRS) bei Erwachsenen ohne vorherige Eingriffe an den Siebbein-Nebenhöhlen. LYR-210 ist ein bioresorbierbares Nasenimplantat, das dazu entwickelt wurde, über einen Zeitraum von sechs Monaten kontinuierlich entzündungshemmende Medikamente (Mometasonfuroat) in die Nasenwege abzugeben.
Das Unternehmen erwartet die Bekanntgabe der wichtigen Ergebnisse im Q2 2025. Diese Studie ist die zweite von zwei entscheidenden Studien zu LYR-210 bei CRS-Patienten. Dr. Maria Palasis, Präsidentin und CEO von Lyra Therapeutics, drückte ihre Dankbarkeit gegenüber den Teilnehmern und Forschern aus, die an den ENLIGHTEN-Studien beteiligt sind, und betonte den potenziellen Nutzen ihrer Technologie für CRS-Patienten.
- Full enrollment achieved for pivotal Phase 3 ENLIGHTEN 2 trial of LYR-210
- LYR-210 offers potential for 6-month continuous anti-inflammatory treatment
- Topline results expected in Q2 2025, indicating progress in clinical development
- None.
Insights
The full enrollment of Lyra Therapeutics' pivotal Phase 3 ENLIGHTEN 2 trial for LYR-210 marks a significant milestone in the development of a novel treatment for chronic rhinosinusitis (CRS). This study focuses on patients who haven't undergone ethmoid sinus surgery, addressing an important subset of the CRS population.
LYR-210's innovative approach of delivering continuous anti-inflammatory medication over six months via a bioresorbable nasal implant could potentially revolutionize CRS management. The extended drug delivery mechanism may offer improved patient compliance and efficacy compared to current treatment options.
With topline results expected in Q2 2025, investors should monitor this closely as positive outcomes could significantly impact Lyra's market position and valuation. However, it's important to note that clinical trial results are never guaranteed and the timeline allows for potential market changes or competitive developments in the interim.
From a financial perspective, the completion of enrollment in the ENLIGHTEN 2 trial is a positive indicator for Lyra Therapeutics. It demonstrates the company's ability to execute on its clinical development plans, which is important for a clinical-stage biotech with a market cap of just
Investors should consider that successful trial results could lead to:
- Increased market valuation
- Potential partnerships or licensing deals
- Improved positioning for future funding rounds or capital raises
However, with results not expected until Q2 2025, Lyra faces the challenge of managing its cash runway. The company will need to carefully balance its resources to reach this critical milestone. Investors should closely monitor Lyra's cash position and burn rate in upcoming quarterly reports.
-- Topline Results Expected Q2 2025 --
WATERTOWN, Mass., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting anti-inflammatory therapies for the localized treatment of chronic rhinosinusitis (CRS), today announced that the pivotal Phase 3 ENLIGHTEN 2 clinical trial of LYR-210 in adult patients with CRS who have not had prior ethmoid sinus surgery, is fully enrolled. LYR-210 is a bioresorbable nasal implant designed to deliver six months of continuous anti-inflammatory medication (mometasone furoate) to the sinonasal passages for the treatment of CRS. Topline results from ENLIGHTEN 2 are expected in Q2 2025.
“We are pleased to have fully enrolled the second of our two pivotal trials of LYR-210 in CRS patients, and our team is moving forward expeditiously to report the results in Q2 of next year,” said Maria Palasis, Ph.D., President and CEO of Lyra Therapeutics. “We thank the participants and the investigators in the ENLIGHTEN studies who have enabled the evaluation of our technology that could potentially benefit patients with CRS.”
About the ENLIGHTEN Pivotal Program
The ENLIGHTEN program consists of two pivotal Phase 3 clinical trials, ENLIGHTEN 1 and ENLIGHTEN 2, to evaluate the efficacy and safety of LYR-210 for the treatment of CRS. Each ENLIGHTEN trial has enrolled approximately 180 CRS patients who have failed medical management and have not had prior ethmoid sinus surgery, randomized 2:1 to either LYR-210 (7500µg mometasone furoate) or sham control for 24 weeks.
About LYR-210
LYR-210 is an investigational product candidate for the treatment of chronic rhinosinusitis (CRS) in patients who have failed current therapies and require further intervention. LYR-210 is a bioresorbable nasal implant designed to be inserted in a simple, in-office procedure. LYR-210 is intended to deliver six months of continuous anti-inflammatory therapy, mometasone furoate, to the sinonasal passages to treat CRS. LYR-210 is being evaluated in the ENLIGHTEN pivotal Phase 3 clinical program.
About Lyra Therapeutics
Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing long-acting, anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis (CRS). Lyra Therapeutics is developing therapies for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210, the company’s lead product, is a bioabsorbable nasal implant designed to be administered in a simple, in-office procedure and is intended to deliver six months of continuous anti-inflammatory drug therapy (7500µg mometasone furoate) to the sinonasal passages for the treatment of CRS with a single administration. LYR-210, being evaluated in the ENLIGHTEN Phase 3 clinical program, is intended for patients with standard anatomy, primarily patients who have not undergone ethmoid sinus surgery. The company’s therapies are intended to treat the estimated four million CRS patients in the United States who fail medical management each year. For more information, please visit www.lyratx.com and follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding whether LYR-210 could potentially benefit patients with CRS, the completion of the Company’s ENLIGHTEN 2 Phase 3 clinical trial, and the timing of the release of topline data from the ENLIGHTEN 2 Phase 3 clinical trial. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These and other important factors discussed under the caption "Risk Factors" in the Company's Quarterly Report on Form 10-Q filed with the SEC on August 14, 2024 and its other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change.
FAQ
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