Polyrizon Commences GMP Manufacturing Preliminary Process for its PL-14 Allergy Blocker in Preparation for Planned 2025 Clinical Trial
Polyrizon has initiated preliminary Good Manufacturing Practice (GMP) manufacturing process for its PL-14 allergy blocker in preparation for planned 2025 clinical trials. The company has partnered with Eurofins CDMO Amatsiaquitaine S.A.S. as their GMP manufacturer to support future commercialization efforts.
The designated manufacturing facility is equipped to meet clinical trial material requirements, ensuring high-quality production and regulatory compliance. The upcoming trial will evaluate PL-14's safety and efficacy as an innovative allergy blocker, delivered through proprietary nasal spray solutions.
According to CEO Tomer Izraeli, the global nasal spray market is projected to exceed $23 billion by 2029. The company aims to address growing market demand with their novel intranasal solution, which they believe could enhance current allergy treatment options.
Polyrizon ha avviato un processo preliminare di Good Manufacturing Practice (GMP) per il suo bloccante allergie PL-14 in preparazione per i previsti trial clinici del 2025. L'azienda ha collaborato con Eurofins CDMO Amatsiaquitaine S.A.S. come loro produttore GMP per supportare futuri sforzi di commercializzazione.
La struttura di produzione designata è attrezzata per soddisfare i requisiti dei materiali per i trial clinici, garantendo una produzione di alta qualità e la conformità alle normative. Il prossimo trial valuterà la sicurezza e l'efficacia del PL-14 come un bloccante allergie innovativo, somministrato tramite soluzioni per spray nasali proprietarie.
Secondo il CEO Tomer Izraeli, il mercato globale degli spray nasali è previsto superare $23 miliardi entro il 2029. L'azienda mira a rispondere alla crescente domanda di mercato con la loro nuova soluzione intranasale, che ritengono possa migliorare le attuali opzioni di trattamento per le allergie.
Polyrizon ha iniciado un proceso preliminar de Buenas Prácticas de Manufactura (GMP) para su bloqueador de alergias PL-14 en preparación para los ensayos clínicos planificados para 2025. La empresa se ha asociado con Eurofins CDMO Amatsiaquitaine S.A.S. como su fabricante GMP para apoyar los futuros esfuerzos de comercialización.
La instalación de fabricación designada está equipada para cumplir con los requisitos de materiales para ensayos clínicos, garantizando producción de alta calidad y cumplimiento normativo. El próximo ensayo evaluará la seguridad y eficacia de PL-14 como un innovador bloqueador de alergias, administrado a través de soluciones de spray nasal proprietarias.
Según el CEO Tomer Izraeli, se prevé que el mercado global de sprays nasales supere los $23 mil millones para 2029. La empresa tiene como objetivo abordar la creciente demanda del mercado con su nueva solución intranasal, que creen que podría mejorar las opciones actuales de tratamiento para alergias.
Polyrizon은 2025년 임상 시험을 준비하기 위해 PL-14 알레르기 차단제의 초기 우수 제조 관행(GMP) 제조 프로세스를 시작했습니다. 이 회사는 향후 상업화 노력을 지원하기 위해 Eurofins CDMO Amatsiaquitaine S.A.S.와 GMP 제조 파트너십을 맺었습니다.
지정된 제조 시설은 임상 시험 물질 요구 사항을 충족할 수 있도록 장비가 갖춰져 있으며, 고품질 생산 및 규제 준수를 보장합니다. 다가오는 시험은 독창적인 알레르기 차단제로서 PL-14의 안전성과 효능을 평가할 예정이며, 독자적 방식의 비강 스프레이 솔루션을 통해 전달됩니다.
CEO Tomer Izraeli에 따르면, 글로벌 비강 스프레이 시장은 2029년까지 $230억을 초과할 것으로 예상됩니다. 이 회사는 현재의 알레르기 치료 옵션을 향상시킬 수 있다고 믿는 새로운 비강 솔루션으로 증가하는 시장 수요에 대응할 계획입니다.
Polyrizon a lancé un processus préliminaire de Bonnes Pratiques de Fabrication (BPF) pour son bloqueur d'allergies PL-14 en préparation des essais cliniques prévus en 2025. L'entreprise s'est associée à Eurofins CDMO Amatsiaquitaine S.A.S. en tant que fabricant BPF pour soutenir les futurs efforts de commercialisation.
La structure de fabrication désignée est équipée pour répondre aux exigences des matériaux d'essai clinique, garantissant une production de haute qualité et le respect des réglementations. Le prochain essai évaluera la sécurité et l'efficacité du PL-14 en tant que bloqueur d'allergies innovant, administré par le biais de solutions de spray nasal propriétaires.
Selon le PDG Tomer Izraeli, le marché mondial des sprays nasaux devrait dépasser 23 milliards de dollars d'ici 2029. L'entreprise vise à répondre à la demande croissante du marché avec sa nouvelle solution intranasale, qu'elle pense pouvoir améliorer les options de traitement actuelles contre les allergies.
Polyrizon hat den vorläufigen Herstellungsprozess nach Guten Herstellungspraktiken (GMP) für seinen PL-14 Allergieblocker eingeleitet, um sich auf die geplanten klinischen Studien im Jahr 2025 vorzubereiten. Das Unternehmen hat sich mit Eurofins CDMO Amatsiaquitaine S.A.S. als ihrem GMP-Hersteller zusammengeschlossen, um die zukünftigen Kommerzialisierungsanstrengungen zu unterstützen.
Die ausgewählte Produktionsstätte ist damit ausgestattet, die Anforderungen an klinische Studienmaterialien zu erfüllen, und gewährleistet eine hochwertige Produktion sowie die Einhaltung der Vorschriften. Die bevorstehende Studie wird die Sicherheit und Wirksamkeit von PL-14 als innovativen Allergieblocker bewerten, der durch eigene Nasenspraylösungen verabreicht wird.
Laut CEO Tomer Izraeli wird erwartet, dass der globale Nasenspraymarkt bis 2029 die 23 Milliarden Dollar übersteigen wird. Das Unternehmen zielt darauf ab, der wachsenden Marktnachfrage mit ihrer neuartigen intranasalen Lösung zu begegnen, von der sie glauben, dass sie die aktuellen Behandlungsoptionen für Allergien verbessern könnte.
- Partnership secured with established GMP manufacturer Eurofins CDMO
- Manufacturing facility ready for clinical trial material production
- Targeting $23 billion nasal spray market by 2029
- Clinical trials not yet started, pending 2025 initiation
- No current revenue generation as still in development stage
- Product efficacy and safety yet to be proven in clinical trials
Insights
The initiation of Good Manufacturing Practice (GMP) manufacturing processes for Polyrizon's PL-14 allergy blocker marks a crucial developmental milestone that directly impacts the company's valuation potential. In simple terms, this is like moving from creating a recipe in a home kitchen to setting up production in a certified commercial facility - a necessary step before any drug can be tested in humans.
The selection of Eurofins CDMO Amatsiaquitaine S.A.S. as manufacturing partner is particularly noteworthy. This established European contract manufacturer brings substantial expertise in GMP production, which typically requires 6-9 months to complete validation processes. The timing aligns well with Polyrizon's planned 2025 clinical trials, though investors should monitor for any potential delays in this critical path.
The market opportunity is substantial, with the nasal spray sector projected to reach
- GMP manufacturing setup typically represents a
$2-5 million investment, impacting near-term cash requirements - The timeline from manufacturing preparation to clinical trial completion usually spans 18-24 months
- Success in manufacturing validation doesn't guarantee clinical trial success, which historically has a
40% success rate in Phase 1
For investors, this development reduces some technical risk but introduces execution risk around manufacturing scale-up. The company's market cap of
Eurofins CDMO Amatsiaquitaine S.A.S., the GMP manufacturer, to support Polyrizon in future commercialization efforts
Raanana, Israel, Jan. 23, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (the "Company" or "Polyrizon"), a development stage biotech company specializing in the development of innovative intranasal hydrogels, announces today it has commenced preliminary work related to the Good Manufacturing Practice (GMP) manufacturing process for its PL-14 allergy blocker in preparation for its planned 2025 clinical trial. The company works closely with Eurofins CDMO, having recently entered into a manufacturing agreement with Eurofins CDMO Amatsiaquitaine S.A.S.
Polyrizon is progressing with preparations for its planned 2025 clinical trial. The designated manufacturing facility is equipped to meet the clinical trial material (CTM) requirements, ensuring high-quality production and compliance with regulatory standards.
The trial aims to assess the safety and efficacy of PL-14 as an innovative allergy blocker, supporting Polyrizon's commitment to addressing allergy-related health challenges with its proprietary nasal spray solutions.
“With the global nasal spray market projected to reach over
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.
About Eurofins CDMO
As a prominent Contract Development & Manufacturing Organization (CDMO), Eurofins CDMO offers a powerful network of companies across Europe, North America and India that provide comprehensive, end-to-end solutions for preclinical and clinical outsourcing services. Eurofins CDMO is specialized in both Drug Substance / API and Drug Product development for Biologics and Small Molecules, helping (bio)pharmaceutical companies swiftly progress from the research phase to the clinical stages.
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 the timing of the commencement of its clinical trial, the growth of the global nasal spray market, its commitment to achieving the highest quality standards for its trial while addressing the market need with a novel intranasal solution that it believes has the potential to enhance current solutions and its future commercialization efforts. 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 prospectus (Registration No. 333-266745), dated October 24, 2024 and filed 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
FAQ
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