Full Press Release Details
Polyrizon Structures Clinical Strategy
for its Allergy Blocker Ahead of FDA Pre-Submission Meeting
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
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:
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.