Polyrizon Structures Clinical Strategy for its Allergy Blocker Ahead of FDA Pre-Submission Meeting
Polyrizon (Nasdaq: PLRZ) has announced its clinical strategy for PL-14, an intranasal allergy blocker designed for seasonal allergic rhinitis. The company has structured a comprehensive clinical plan ahead of a pre-submission meeting with the FDA.
The clinical studies will evaluate three key aspects:
- Efficacy and safety under natural exposure during peak allergy season
- Human Factors study for usability and patient acceptance
- Assessment of nasal residence time of the PL-14 formulation
The biotech company plans to initiate clinical trials in the U.S. and Europe between late 2025 and early 2026, following preclinical work completion and FDA consultation.
Polyrizon (Nasdaq: PLRZ) ha annunciato la sua strategia clinica per PL-14, un bloccante per allergie intranasale progettato per la rinite allergica stagionale. L'azienda ha strutturato un piano clinico completo in vista di un incontro di pre-sottomissione con la FDA.
Gli studi clinici valuteranno tre aspetti chiave:
- Efficacia e sicurezza in condizioni di esposizione naturale durante il picco della stagione allergica
- Studio sui Fattori Umani per l'usabilità e l'accettazione da parte dei pazienti
- Valutazione del tempo di residenza nasale della formulazione PL-14
La società biotech prevede di avviare sperimentazioni cliniche negli Stati Uniti e in Europa tra la fine del 2025 e l'inizio del 2026, dopo il completamento del lavoro preclinico e la consultazione con la FDA.
Polyrizon (Nasdaq: PLRZ) ha anunciado su estrategia clínica para PL-14, un bloqueador de alergias intranasal diseñado para la rinitis alérgica estacional. La compañía ha estructurado un plan clínico integral antes de una reunión de pre-sumisión con la FDA.
Los estudios clínicos evaluarán tres aspectos clave:
- Eficacia y seguridad bajo exposición natural durante la temporada alta de alergias
- Estudio de Factores Humanos para la usabilidad y aceptación por parte de los pacientes
- Evaluación del tiempo de residencia nasal de la formulación PL-14
La empresa biotecnológica planea iniciar ensayos clínicos en EE.UU. y Europa entre finales de 2025 y principios de 2026, tras la finalización del trabajo preclínico y la consulta con la FDA.
폴리리존 (Nasdaq: PLRZ)은 계절성 알레르기 비염을 위한 비강 알레르기 차단제인 PL-14의 임상 전략을 발표했습니다. 이 회사는 FDA와의 사전 제출 회의를 앞두고 포괄적인 임상 계획을 수립했습니다.
임상 연구는 세 가지 주요 측면을 평가할 것입니다:
- 알레르기 시즌의 자연 노출 하에서의 효능 및 안전성
- 사용성 및 환자 수용성을 위한 인간 요인 연구
- PL-14 제형의 비강 체류 시간 평가
이 생명공학 회사는 사전 임상 작업 완료 및 FDA 상담 후 2025년 말에서 2026년 초 사이에 미국과 유럽에서 임상 시험을 시작할 계획입니다.
Polyrizon (Nasdaq: PLRZ) a annoncé sa stratégie clinique pour PL-14, un bloqueur d'allergies intranasal conçu pour la rhinite allergique saisonnière. L'entreprise a structuré un plan clinique complet en vue d'une réunion de pré-soumission avec la FDA.
Les études cliniques évalueront trois aspects clés :
- Efficacité et sécurité lors d'une exposition naturelle durant la saison allergique de pointe
- Étude sur les facteurs humains pour l'utilisabilité et l'acceptation par les patients
- Évaluation du temps de résidence nasal de la formulation PL-14
L'entreprise biotechnologique prévoit de commencer des essais cliniques aux États-Unis et en Europe entre fin 2025 et début 2026, après l'achèvement des travaux précliniques et la consultation avec la FDA.
Polyrizon (Nasdaq: PLRZ) hat seine klinische Strategie für PL-14, einen intranasalen Allergieblocker, der für saisonale allergische Rhinitis entwickelt wurde, angekündigt. Das Unternehmen hat einen umfassenden klinischen Plan im Vorfeld eines Vorab-Submission-Meetings mit der FDA strukturiert.
Die klinischen Studien werden drei zentrale Aspekte bewerten:
- Wirksamkeit und Sicherheit bei natürlicher Exposition während der Hochsaison für Allergien
- Studie zu menschlichen Faktoren zur Benutzerfreundlichkeit und Patientenakzeptanz
- Bewertung der Nasenverweildauer der PL-14-Formulierung
Das Biotechnologieunternehmen plant, zwischen Ende 2025 und Anfang 2026 klinische Studien in den USA und Europa zu starten, nachdem die präklinische Arbeit abgeschlossen und die FDA konsultiert wurde.
- Clear regulatory pathway established with structured clinical strategy
- Comprehensive three-pronged clinical study approach
- Large market potential targeting millions with allergic rhinitis
- Clinical trials won't begin until late 2025/early 2026
- Multiple clinical studies required before potential approval
- Pre-clinical work still pending completion
Studies to assess efficacy, safety, user experience, and nasal residence time as Company prepares for regulatory path forward
Raanana, Israel, March 27, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ), a biotech company specializing in innovative intranasal hydrogels, today announced the structuring of its clinical strategy for PL-14, the Company’s proprietary intranasal allergy blocker for seasonal allergic rhinitis.
The clinical strategy was updated in preparation for a planned pre-submission meeting with the U.S. Food and Drug Administration (FDA), which is expected to be followed by the initiation of clinical trials.
The comprehensive clinical studies is expected to include:
- A clinical study evaluating efficacy and safety under natural exposure conditions during peak allergy season
- A dedicated Human Factors (HF) study designed to assess usability and patient acceptance of PL-14
- An additional clinical study assessing the nasal residence time of the PL-14 formulation.
Tomer Izraeli, CEO of Polyrizon, said: “Structuring our clinical plan brings us closer to our goal of advancing PL-14 toward regulatory approval and commercialization. By generating strong data around efficacy, safety and user experience, we believe PL-14 can provide meaningful value to millions suffering from allergic rhinitis.”
Polyrizon expects to initiate clinical trials in the U.S. and Europe in late 2025 to early 2026, following the completion of preclinical work and the upcoming FDA consultation.
About Polyrizon Ltd.
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 its goal of advancing PL-14 toward regulatory approval and commercialization, its belief that PL-14 can provide meaningful value to millions suffering from allergic rhinitis and its expectation to initiate clinical trials in the U.S. and Europe in late 2025 to early 2026, following the completion of preclinical work and the upcoming FDA consultation. 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
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