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Polyrizon Launches Preclinical Studies for Intranasal Naloxone to Combat Opioid Overdose Using Cutting-Edge Platform

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Polyrizon (Nasdaq: PLRZ) has initiated preclinical studies for intranasal Naloxone using their proprietary Trap and Target™ (T&T) platform. The studies, conducted in collaboration with Professor Fabio Sonvico from the University of Parma, will evaluate key parameters including drug loading capacity, release kinetics, nasal deposition, and stability.

The company aims to enhance intranasal Naloxone delivery to combat the global opioid crisis by potentially offering higher bioavailability and optimized drug release profiles. This development targets the growing Naloxone market, projected to reach $2.47 billion by 2032 with an 11% CAGR, where the intranasal spray segment alone is expected to reach $1.4 billion by 2030.

Intranasal delivery offers several advantages including easier administration, no need for trained medical personnel, reduced needlestick injury risks, and increased accessibility for emergency responders and at-risk individuals.

Polyrizon (Nasdaq: PLRZ) ha avviato studi preclinici per il Naloxone intranasale utilizzando la loro piattaforma proprietaria Trap and Target™ (T&T). Gli studi, condotti in collaborazione con il Professor Fabio Sonvico dell'Università di Parma, valuteranno parametri chiave tra cui la capacità di carico del farmaco, la cinetica di rilascio, la deposizione nasale e la stabilità.

L'azienda mira a migliorare la somministrazione intranasale del Naloxone per affrontare la crisi globale degli oppioidi, offrendo potenzialmente una maggiore biodisponibilità e profili di rilascio del farmaco ottimizzati. Questo sviluppo si rivolge al crescente mercato del Naloxone, previsto raggiungere 2,47 miliardi di dollari entro il 2032 con un CAGR dell'11%, dove il segmento degli spray intranasali da solo dovrebbe raggiungere 1,4 miliardi di dollari entro il 2030.

La somministrazione intranasale offre diversi vantaggi, tra cui una somministrazione più semplice, non necessità di personale medico formato, ridotto rischio di infortuni da puntura e maggiore accessibilità per i soccorritori e le persone a rischio.

Polyrizon (Nasdaq: PLRZ) ha iniciado estudios preclínicos para el Naloxona intranasal utilizando su plataforma propietaria Trap and Target™ (T&T). Los estudios, realizados en colaboración con el Profesor Fabio Sonvico de la Universidad de Parma, evaluarán parámetros clave como la capacidad de carga del fármaco, la cinética de liberación, la deposición nasal y la estabilidad.

La empresa tiene como objetivo mejorar la administración intranasal de Naloxona para combatir la crisis global de opioides, ofreciendo potencialmente una mayor biodisponibilidad y perfiles de liberación del fármaco optimizados. Este desarrollo se dirige al creciente mercado de Naloxona, que se proyecta alcanzará 2.47 mil millones de dólares para 2032 con una tasa de crecimiento anual compuesta (CAGR) del 11%, donde el segmento de aerosoles intranasales solo se espera que alcance 1.4 mil millones de dólares para 2030.

La entrega intranasal ofrece varias ventajas, incluyendo una administración más fácil, sin necesidad de personal médico capacitado, menor riesgo de lesiones por pinchazos y mayor accesibilidad para los primeros respondedores y personas en riesgo.

Polyrizon (Nasdaq: PLRZ)는 독점 플랫폼 Trap and Target™ (T&T)를 사용하여 비강 내 Naloxone에 대한 전임상 연구를 시작했습니다. 이 연구는 파르마 대학교의 파비오 손비코 교수와 협력하여 수행되며, 약물 적재 용량, 방출 동력학, 비강 침착 및 안정성과 같은 주요 매개 변수를 평가할 것입니다.

회사는 글로벌 오피오이드 위기를 해결하기 위해 비강 내 Naloxone 전달을 향상시키고, 잠재적으로 높은 생체이용률과 최적화된 약물 방출 프로필을 제공하는 것을 목표로 하고 있습니다. 이 개발은 2032년까지 24억 7천만 달러에 이를 것으로 예상되는 증가하는 Naloxone 시장을 목표로 하며, 비강 스프레이 세그먼트만으로도 2030년까지 14억 달러에 이를 것으로 예상됩니다.

비강 전달은 더 쉬운 관리, 훈련된 의료 인력의 필요 없음, 바늘 상해 위험 감소, 응급 구조원 및 위험에 처한 개인을 위한 접근성 증가 등 여러 가지 장점을 제공합니다.

Polyrizon (Nasdaq: PLRZ) a lancé des études précliniques pour le Naloxone intranasal en utilisant sa plateforme propriétaire Trap and Target™ (T&T). Les études, menées en collaboration avec le professeur Fabio Sonvico de l'Université de Parme, évalueront des paramètres clés tels que la capacité de chargement du médicament, la cinétique de libération, la déposition nasale et la stabilité.

L'entreprise vise à améliorer l'administration intranasale du Naloxone pour lutter contre la crise mondiale des opioïdes, en offrant potentiellement une biodisponibilité plus élevée et des profils de libération du médicament optimisés. Ce développement cible le marché croissant du Naloxone, qui devrait atteindre 2,47 milliards de dollars d'ici 2032 avec un taux de croissance annuel composé (CAGR) de 11 %, où le segment des sprays intranasaux devrait à lui seul atteindre 1,4 milliard de dollars d'ici 2030.

La délivrance intranasale offre plusieurs avantages, notamment une administration plus facile, l'absence de besoin de personnel médical formé, une réduction des risques de blessures par piqûre et une accessibilité accrue pour les secouristes et les personnes à risque.

Polyrizon (Nasdaq: PLRZ) hat präklinische Studien zur intranasalen Verabreichung von Naloxon mit ihrer proprietären Trap and Target™ (T&T)-Plattform initiiert. Die Studien, die in Zusammenarbeit mit Professor Fabio Sonvico von der Universität Parma durchgeführt werden, werden wichtige Parameter wie die Arzneimittelbeladungskapazität, die Freisetzungskinetik, die nasale Ablagerung und die Stabilität bewerten.

Das Unternehmen zielt darauf ab, die intranasale Naloxon-Abgabe zu verbessern, um die globale Opioidkrise zu bekämpfen, indem es potenziell eine höhere Bioverfügbarkeit und optimierte Arzneimittelfreisetzungsprofile bietet. Diese Entwicklung richtet sich an den wachsenden Naloxon-Markt, der voraussichtlich bis 2032 2,47 Milliarden US-Dollar erreichen wird bei einer jährlichen Wachstumsrate (CAGR) von 11 %, wobei der Segment der intranasalen Sprays allein bis 2030 1,4 Milliarden US-Dollar erreichen soll.

Die intranasale Abgabe bietet mehrere Vorteile, einschließlich einfacherer Verabreichung, keine Notwendigkeit für geschultes medizinisches Personal, reduzierte Risiken von Nadelverletzungen und erhöhte Zugänglichkeit für Notfallhelfer und gefährdete Personen.

Positive
  • Entering growing market with $2.47B potential by 2032 (11% CAGR)
  • Intranasal spray segment specifically projected to reach $1.4B by 2030
  • Partnership with leading expert in intranasal drug delivery
  • Platform potentially offers higher bioavailability and optimized drug release
Negative
  • Still in early preclinical stage with no proven efficacy
  • No revenue generation from product in near term
  • Success dependent on future clinical trials and FDA approval

Insights

Polyrizon's initiation of preclinical studies for intranasal Naloxone represents an early-stage milestone in their development pipeline, but investors should understand the significant journey ahead. The company's proprietary Trap and Target™ platform will be evaluated for fundamental parameters including drug loading capacity, release kinetics, and stability - all critical factors that determine whether a drug delivery technology has merit.

The collaboration with Professor Sonvico brings valuable expertise, but this announcement marks just the beginning of a lengthy development process. Preclinical studies typically precede IND-enabling studies, clinical trials, and regulatory submissions - a pathway that often spans 5-7 years minimum. The intranasal route offers theoretical advantages for Naloxone delivery including rapid absorption across the nasal mucosa and bypassing first-pass metabolism.

While the medical need is substantial, several intranasal Naloxone products already exist on the market. Polyrizon will need to demonstrate meaningful differentiation through enhanced bioavailability or improved release profiles to gain market traction. The technical hurdles are significant - achieving consistent drug delivery through the nasal cavity presents formulation challenges, and the company has yet to generate data demonstrating their platform's advantages over existing technologies.

The strategic positioning of Polyrizon in the Naloxone market warrants attention, given the projected $2.47 billion global market by 2032, growing at 11% CAGR. The intranasal segment specifically is expected to reach $1.4 billion by 2030, indicating significant commercial potential if development succeeds.

However, this announcement represents the earliest stage of pharmaceutical development with no guaranteed path to commercialization. As a development-stage biotech company, Polyrizon faces the standard industry challenges of high R&D costs, regulatory hurdles, and significant development timelines before potential revenue generation.

The market dynamics are complex - while the opioid crisis creates sustained demand, Polyrizon would enter a competitive landscape with established players. The company hasn't disclosed detailed development timelines, funding requirements for clinical progression, or specific technical advantages over existing formulations. This makes it difficult to assess the probability of market success or timeline to potential commercialization.

For investors, this represents a strategic research direction with significant addressable market but comes with all the inherent risks of early-stage drug development, including the statistics showing that most candidates at the preclinical stage never reach market approval.

Raanana, Israel, March 13, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (the "Company" or "Polyrizon"), a development stage biotech company specializing in the development of innovative intranasal hydrogels, previously announced the initiation of preclinical studies for intranasal Naloxone, a life-saving opioid overdose treatment.

As previously announced, the study will be conducted in collaboration with Professor Fabio Sonvico, Associate Professor at the Department of Food and Drug of the University of Parma (Italy) a leading expert in the development of intranasal and pulmonary drug delivery solutions and a member of the Company's Scientific Advisory Board.

These preclinical studies mark a step forward in evaluating Polyrizon's Trap and Target™ (T&T) platform for the intranasal administration of Naloxone, an opioid antagonist designed to rapidly reverse opioid overdose. These studies will assess key parameters, such as drug loading capacity, release kinetics, nasal deposition and stability, laying the groundwork for further safety and efficacy testing in preclinical and clinical studies.

"The opioid crisis continues to be a global public health emergency and improving Naloxone administration is essential for saving lives," said Tomer Izraeli CEO of Polyrizon. "Our proprietary T&T platform is designed to optimize drug delivery, and we believe it holds the potential to enhance intranasal Naloxone by offering higher bioavailability for increased drug effectiveness and optimized drug release profiles that ensure rapid opioid reversal when every second counts. These advantages could make a critical difference in emergency overdose situations, providing a safer and more accessible solution for at-risk individuals and first responders."

The ongoing opioid epidemic, largely driven by fentanyl and other synthetic opioids, has led to a dramatic rise in overdose fatalities worldwide. Naloxone, an FDA-approved opioid antagonist, has been shown to reverse opioid toxicity when administered promptly after respiratory depression occurs. The global Naloxone market is projected to reach $2.47 billion by 2032, growing at a CAGR of 11%The Naloxone intranasal spray market alone is expected to reach $1.4 billion by 2030 (Vantage Market Research, February 2022).

Intranasal delivery of Naloxone presents several advantages, including ease of administration, eliminating the need for trained medical personnel, reduced risk of needlestick injuries and increased accessibility, allowing emergency responders, caregivers, and at-risk individuals to carry and use it effectively.

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 its belief that its Trap and Target™ (T&T) platform holds the potential to enhance intranasal Naloxone by offering higher bioavailability for increased drug effectiveness and optimized drug release profiles that ensure rapid opioid reversal. 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

IR@polyrizon-biotech.com


FAQ

What is the market potential for Polyrizon's (PLRZ) intranasal Naloxone development?

The global Naloxone market is projected to reach $2.47 billion by 2032, with the intranasal spray segment expected to reach $1.4 billion by 2030.

What advantages does Polyrizon's (PLRZ) intranasal Naloxone delivery system offer?

The T&T platform aims to provide higher bioavailability, optimized drug release profiles, easier administration, and increased accessibility without requiring trained medical personnel.

What stage is Polyrizon's (PLRZ) intranasal Naloxone development currently in?

Polyrizon has initiated preclinical studies to evaluate drug loading capacity, release kinetics, nasal deposition, and stability.

Who is collaborating with Polyrizon (PLRZ) on the intranasal Naloxone development?

Professor Fabio Sonvico from the University of Parma, a leading expert in intranasal drug delivery and member of Polyrizon's Scientific Advisory Board.
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