Polyrizon Initiates Preclinical Studies for Intranasal Naloxone Targeting Opioid Overdose Based on Its Innovative T&T Platform

Rhea-AI Summary

Polyrizon (Nasdaq: PLRZ) has initiated preclinical studies for intranasal Naloxone, targeting opioid overdose treatment using its proprietary Trap and Target™ (T&T) platform. The study will be conducted in collaboration with Professor Fabio Sonvico from the University of Parma, focusing on key parameters like drug loading capacity, release kinetics, nasal deposition, and stability.

The company aims to enhance intranasal Naloxone delivery by improving bioavailability and optimizing drug release profiles for rapid opioid reversal in emergency situations. This development addresses the ongoing global opioid crisis, particularly driven by fentanyl and synthetic opioids.

Market projections indicate significant growth potential:

• Global Naloxone market expected to reach $2.47 billion by 2032 (11% CAGR)
• Naloxone intranasal spray market projected to hit $1.4 billion by 2030

Positive

• Entering preclinical studies phase for intranasal Naloxone development
• Targeting large market opportunity: $2.47B global Naloxone market by 2032
• Partnership with leading expert in intranasal drug delivery
• Proprietary T&T platform could provide competitive advantages in drug delivery

Negative

• Early-stage development (preclinical phase) with no guaranteed success
• Company still in development stage with no commercial products
• Facing established competition in the Naloxone market

Insights

Biotech Research Analyst

Polyrizon's initiation of preclinical studies for intranasal Naloxone represents a strategic early-stage research milestone for this micro-cap biotech company. The company is targeting the opioid overdose treatment market with its Trap and Target™ (T&T) platform technology, which could potentially enhance drug delivery effectiveness.

The planned preclinical studies will evaluate fundamental parameters such as drug loading capacity, release kinetics, nasal deposition and stability - essential foundational work that must precede any safety or efficacy testing. This represents the first step in a lengthy development process that typically includes multiple preclinical studies, IND filing, and phased clinical trials before potential regulatory approval.

The market opportunity is substantial, with the global Naloxone market projected to reach $2.47 billion by 2032 (growing at 11% CAGR) and the intranasal segment specifically expected to reach $1.4 billion by 2030. However, investors should recognize this space already has established competitors with approved products.

For a company with a market capitalization of just $3.45 million, advancing a drug candidate through the complete development pathway will likely require significant additional funding or strategic partnerships beyond this initial research collaboration. The collaboration with Professor Sonvico adds scientific credibility to their approach, but does not guarantee technical or commercial success.

This announcement establishes a potential development trajectory but represents an extremely early stage in pharmaceutical development with significant technical, regulatory, and commercial hurdles ahead.

Pharmaceutical Market Specialist

Polyrizon's entry into the intranasal Naloxone space positions them in a growing market segment with established clinical need. Their approach focuses on potentially addressing key limitations of current intranasal Naloxone formulations through their proprietary T&T platform technology.

The intranasal route offers substantial advantages over injectable Naloxone - including ease of administration by non-medical personnel, elimination of needlestick risks, and significantly improved accessibility in emergency situations. These benefits have driven substantial market growth for intranasal formulations.

However, this market already has FDA-approved competitors (like Narcan® and generic alternatives), creating a high bar for differentiation. For Polyrizon to capture meaningful market share, their technology would need to demonstrate clear advantages in either bioavailability, onset of action, cost, or convenience - outcomes that remain entirely theoretical at this preclinical stage.

The company's market capitalization of $3.45 million raises questions about their capacity to fund complete development, as advancing through clinical trials typically requires tens of millions in capital. This creates a likely future need for dilutive financing or partnership deals.

While the underlying market trend is positive, with governments and healthcare systems expanding Naloxone access to combat rising overdose deaths, investors should view this announcement as establishing a potential development program rather than a near-term value driver. The timeline from preclinical studies to potential commercialization typically spans 5+ years, assuming successful progression through all development phases.

Raanana, Israel, March 10, 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 initiation of preclinical studies for intranasal Naloxone, a life-saving opioid overdose treatment.

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 $2.47B by 2032 (11% CAGR), with the intranasal spray segment expected to reach $1.4B by 2030.

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

It offers higher bioavailability, optimized drug release profiles, easier administration, reduced needlestick injury risk, and increased accessibility for emergency responders and caregivers.

What parameters will Polyrizon's (PLRZ) preclinical studies evaluate for intranasal Naloxone?

The studies will assess drug loading capacity, release kinetics, nasal deposition, and stability parameters.

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

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