Polyrizon Reports Successful Safety Study of a Formulation of PL-14 Allergy Blocker in Human Nasal Tissue Model
Polyrizon (NASDAQ: PLRZ) has announced successful preliminary safety study results for its PL-14 Allergy Blocker formulation, tested on human nasal tissue using the MucilAir™ model. The study evaluated the local tolerability of the mucoadhesive nasal gel spray, designed to create a physical barrier against airborne allergens with a 4-hour effectiveness window.
The safety assessment measured key indicators including tissue integrity, cytotoxicity, cilia beating frequency, mucociliary clearance, and inflammatory response. Results showed tissue viability and function remained consistent with baseline and vehicle controls, with no signs of inflammatory activation or functional impairment.
This milestone supports Polyrizon's regulatory strategy and upcoming FDA pre-submission meeting. The company plans to initiate U.S. and European clinical trials in late 2025 or early 2026.
Polyrizon (NASDAQ: PLRZ) ha annunciato i risultati preliminari positivi di uno studio di sicurezza sulla sua formulazione PL-14 Allergy Blocker, testata su tessuto nasale umano utilizzando il modello MucilAir™. Lo studio ha valutato la tollerabilità locale del gel nasale mucoadesivo spray, progettato per creare una barriera fisica contro gli allergeni trasportati dall’aria, con un’efficacia di 4 ore.
La valutazione della sicurezza ha misurato indicatori chiave quali integrità del tessuto, citotossicità, frequenza del battito ciliare, clearance mucociliare e risposta infiammatoria. I risultati hanno mostrato che la vitalità e la funzionalità del tessuto sono rimaste invariate rispetto ai valori di riferimento e ai controlli con veicolo, senza segni di attivazione infiammatoria o compromissione funzionale.
Questo traguardo supporta la strategia regolatoria di Polyrizon e l’imminente incontro pre-sottomissione con la FDA. L’azienda prevede di avviare trial clinici negli Stati Uniti e in Europa tra la fine del 2025 e l’inizio del 2026.
Polyrizon (NASDAQ: PLRZ) ha anunciado resultados preliminares exitosos de un estudio de seguridad para su formulación PL-14 Allergy Blocker, probada en tejido nasal humano utilizando el modelo MucilAir™. El estudio evaluó la tolerabilidad local del gel nasal mucoadhesivo en spray, diseñado para crear una barrera física contra alérgenos en el aire con una efectividad de 4 horas.
La evaluación de seguridad midió indicadores clave como la integridad del tejido, citotoxicidad, frecuencia del latido ciliar, aclaramiento mucociliar y respuesta inflamatoria. Los resultados mostraron que la viabilidad y función del tejido se mantuvieron consistentes con la línea base y los controles con vehículo, sin signos de activación inflamatoria o deterioro funcional.
Este logro respalda la estrategia regulatoria de Polyrizon y la próxima reunión pre-sumisión con la FDA. La compañía planea iniciar ensayos clínicos en EE. UU. y Europa a finales de 2025 o principios de 2026.
폴리라이존 (NASDAQ: PLRZ)이 MucilAir™ 모델을 사용해 인간 비강 조직에서 시험한 PL-14 알레르기 차단제 제형의 예비 안전성 연구 결과를 성공적으로 발표했습니다. 이 연구는 공기 중 알레르겐에 대한 물리적 장벽을 형성하도록 설계된 점착성 비강 겔 스프레이의 국소 내성 평가를 진행했으며, 효과 지속 시간은 4시간입니다.
안전성 평가는 조직 무결성, 세포독성, 섬모 박동 빈도, 점액 섬모 청소율, 염증 반응 등 주요 지표를 측정했습니다. 결과는 조직 생존력과 기능이 기준선 및 대조군과 일치하며, 염증 활성화나 기능 저하 징후가 없음을 보여주었습니다.
이 성과는 폴리라이존의 규제 전략과 다가오는 FDA 사전 제출 회의를 지원합니다. 회사는 2025년 말 또는 2026년 초에 미국과 유럽에서 임상시험을 시작할 계획입니다.
Polyrizon (NASDAQ : PLRZ) a annoncé des résultats préliminaires positifs concernant l’étude de sécurité de sa formulation PL-14 Allergy Blocker, testée sur du tissu nasal humain à l’aide du modèle MucilAir™. L’étude a évalué la tolérance locale du spray nasal en gel mucoadhésif, conçu pour créer une barrière physique contre les allergènes aéroportés avec une efficacité de 4 heures.
L’évaluation de la sécurité a mesuré des indicateurs clés tels que l’intégrité tissulaire, la cytotoxicité, la fréquence des battements ciliaires, le clairance mucociliaire et la réponse inflammatoire. Les résultats ont montré que la viabilité et la fonction du tissu restaient conformes aux valeurs de référence et aux témoins véhicules, sans signe d’activation inflammatoire ni d’altération fonctionnelle.
Cette avancée soutient la stratégie réglementaire de Polyrizon et la prochaine réunion pré-soumission avec la FDA. La société prévoit de lancer des essais cliniques aux États-Unis et en Europe fin 2025 ou début 2026.
Polyrizon (NASDAQ: PLRZ) hat erfolgreiche vorläufige Sicherheitsergebnisse für seine PL-14 Allergy Blocker-Formulierung bekannt gegeben, die an menschlichem Nasengewebe mit dem MucilAir™-Modell getestet wurde. Die Studie bewertete die lokale Verträglichkeit des mucoadhäsiven Nasengel-Sprays, das eine physikalische Barriere gegen luftgetragene Allergene mit einer Wirkdauer von 4 Stunden schaffen soll.
Die Sicherheitsbewertung umfasste wichtige Indikatoren wie Gewebeintegrität, Zytotoxizität, Flimmerfrequenz, mukoziliäre Clearance und Entzündungsreaktion. Die Ergebnisse zeigten, dass Gewebeviabilität und -funktion im Vergleich zu Basiswerten und Vehikelkontrollen unverändert blieben, ohne Anzeichen einer Entzündungsaktivierung oder Funktionsbeeinträchtigung.
Dieser Meilenstein unterstützt Polyrizons regulatorische Strategie und das bevorstehende FDA-Vorabtreffen. Das Unternehmen plant, Ende 2025 oder Anfang 2026 klinische Studien in den USA und Europa zu starten.
- Successful completion of preliminary safety study for PL-14 Allergy Blocker
- Product demonstrated strong local tolerability in human nasal tissue
- No adverse effects observed in key safety indicators
- Advancement towards FDA pre-submission meeting
- Product still in early development stage
- Clinical trials not expected to begin until late 2025/early 2026
- No revenue generation potential in near term
Insights
Polyrizon's safety study success marks promising development milestone, though commercial product remains years away.
Polyrizon's successful preliminary safety study for a formulation of PL-14 Allergy Blocker represents a meaningful early milestone in their product development pathway. The study utilized the MucilAir™ human nasal tissue model to evaluate multiple critical safety parameters including tissue integrity (TEER), cytotoxicity (LDH), cilia beating frequency (CBF), mucociliary clearance (MCC), and inflammatory response (IL-8 secretion).
The positive results demonstrating strong local tolerability without signs of inflammatory activation or functional impairment of nasal epithelial activity are particularly significant for a product designed to remain in the nasal cavity for approximately 4 hours post-application. This safety profile is essential for a mucoadhesive nasal gel intended for regular use as a protective barrier against airborne allergens.
From a development perspective, this successful tissue model testing provides crucial validation before advancing to human clinical trials. The company's approach using a drug-free physical barrier mechanism could potentially offer advantages over pharmacological interventions, though efficacy remains to be demonstrated in clinical settings.
This milestone contributes to Polyrizon's verification and validation program ahead of their FDA pre-submission meeting. However, with clinical trials not expected until late 2025 or early 2026, the commercial timeline remains extended. For a development-stage biotech with a
Raanana, Israel, April 25, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (the “Company” or “Polyrizon”), a development stage biotech company specializing in the development of innovative intranasal hydrogels, announced today the successful preliminary safety study for a formulation of its PL-14 Allergy Blocker, marking a significant advancement in the product’s development path.
Conducted on fully differentiated human nasal tissue using the MucilAir™ model, the study demonstrated strong local tolerability, a critical benchmark in the product development roadmap.
The study was designed to assess local tolerance and tissue response following a 4-hour application of a formulation of PL-14, a mucoadhesive nasal gel spray formulated to act as a physical barrier against airborne allergens. PL-14 Allergy Blocker is intended to remain in the nasal cavity for approximately 4 hours post-application.
Key safety indicators, including tissue integrity (TEER), cytotoxicity (LDH), cilia beating frequency (CBF), mucociliary clearance (MCC), and inflammatory response (IL-8 secretion), were evaluated in comparison to untreated and vehicle control groups. Tissue viability and function remained consistent with baseline and vehicle controls. No signs of inflammatory activation or functional impairment of nasal epithelial activity were observed under the tested conditions.
“These results represent an important milestone in validating the local safety of a formulation of PL-14 3D polymeric network and provide foundational support for advancing our clinical development,” said Mr. Tomer Izraeli, CEO of Polyrizon. “Our goal is to offer a drug-free, well-tolerated nasal spray that provides daily protection against airborne allergens by forming a stable physical barrier in the nasal cavity.”
This contributes to the company’s broader verification and validation (V&V) program ahead of its planned clinical trials and FDA pre-submission meeting.
The data serve as a key step in Polyrizon’s regulatory strategy and will support its upcoming FDA pre-submission meeting, paving the way for U.S. and European clinical trials expected to begin in late 2025 or early 2026.
About Polyrizon
Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target ™, or T&T. For more information, please visit https://polyrizon-biotech.com.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses advancing its clinical development and the expected commencement dates of its U.S. and European clinical trials. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report filed with the SEC on March 11, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Polyrizon is not responsible for the contents of third-party websites.
Contacts:
Michal Efraty
Investor Relations
IR@polyrizon-biotech.com
FAQ
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