Full Press Release Details
Reports Successful Safety Study of a Formulation of PL-14 Allergy Blocker in Human Nasal Tissue Model
Raanana, Israel, April 25, 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 successful preliminary safety study for a formulation of its
PL-14 Allergy Blocker, marking a significant advancement in the product's development path.
on fully differentiated human nasal tissue using the MucilAir model, the study demonstrated strong local tolerability, a critical
benchmark in the product development roadmap.
study was designed to assess local tolerance and tissue response following a 4-hour application of a formulation of PL-14, a
mucoadhesive nasal gel spray formulated to act as a physical barrier against airborne allergens. PL-14 Allergy Blocker is intended
to remain in the nasal cavity for approximately 4 hours post-application.
safety indicators, including tissue integrity (TEER), cytotoxicity (LDH), cilia beating frequency (CBF), mucociliary clearance (MCC),
and inflammatory response (IL-8 secretion), were evaluated in comparison to untreated and vehicle control groups. Tissue viability and
function remained consistent with baseline and vehicle controls. No signs of inflammatory activation or functional impairment of nasal
epithelial activity were observed under the tested conditions.
results represent an important milestone in validating the local safety of a formulation of PL-14 3D polymeric network and provide
foundational support for advancing our clinical development," said Mr. Tomer Izraeli, CEO of Polyrizon. "Our goal is to
offer a drug-free, well-tolerated nasal spray that provides daily protection against airborne allergens by forming a stable physical
barrier in the nasal cavity."
contributes to the company's broader verification and validation (V&V) program ahead of its planned clinical trials and FDA
pre-submission meeting.
data serve as a key step in Polyrizon's regulatory strategy and will support its upcoming FDA pre-submission meeting, paving the
way for U.S. and European clinical trials expected to begin in late 2025 or early 2026.
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
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clinical development and the expected commencement dates of its U.S. and European clinical trials. Forward-looking statements are not
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annual report filed with the SEC on March 11, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the
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events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent
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