Polyrizon Reports Successful Safety Study of a Formulation of Allergy Blocker in Human Nasal Tissue Model

Polyrizon Ltd. recently announced the successful preliminary safety study for a formulation of its PL-14 Allergy Blocker, marking a significant advancement in the product’s development path.

Conducted on fully differentiated human nasal tissue using the MucilAir model, the study demonstrated strong local tolerability, a critical benchmark in the product development roadmap.

The 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.

Key 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.

“These 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.”

This contributes to the company’s broader verification and validation (V&V) program ahead of its planned clinical trials and FDA pre-submission meeting.

The data serve as a key step in Polyrizon’s regulatory strategy and will support its upcoming FDA pre-submission meeting, paving the way for US and European clinical trials expected to begin in late 2025 or early 2026.

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, 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.