Polyrizon Structures Clinical Strategy for its Allergy Blocker Ahead of FDA Pre-Submission Meeting

March 27, 2025 08:25 ET | Source: Polyrizon Ltd. 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 seasonA dedicated Human Factors (HF) study designed to assess usability and patient acceptance of PL-14An 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 IR@polyrizon-biotech.com

Polyrizon Structures Clinical Strategy for its Allergy Blocker Ahead of FDA Pre-Submission Meeting

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