Polyrizon Ltd. (Nasdaq: PLRZ) has announced significant progress in the development of its PL-14 intranasal allergy blocker for seasonal allergic rhinitis, reporting successful safety study results and finalizing its clinical strategy ahead of regulatory consultations.
The biotechnology company, which specializes in innovative intranasal hydrogels, recently completed a preliminary safety study for a formulation of PL-14 using the MucilAir™ model of fully differentiated human nasal tissue. The study demonstrated strong local tolerability following a 4-hour application of the product.
"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 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."
Safety Study Details
The safety assessment evaluated multiple key indicators including tissue integrity (TEER), cytotoxicity (LDH), cilia beating frequency (CBF), mucociliary clearance (MCC), and inflammatory response (IL-8 secretion). Researchers compared these metrics against untreated and vehicle control groups.
According to the company, tissue viability and function remained consistent with baseline and vehicle controls throughout the testing period. Importantly, no signs of inflammatory activation or functional impairment of nasal epithelial activity were observed under the tested conditions.
This safety data represents a critical component of Polyrizon's broader verification and validation program as the company prepares for clinical trials.
Comprehensive Clinical Strategy
In parallel with the safety study, Polyrizon has structured its clinical strategy for PL-14 in preparation for a planned pre-submission meeting with the U.S. Food and Drug Administration (FDA).
The company's comprehensive clinical program is expected to include:
- A clinical study evaluating efficacy and safety under natural exposure conditions during peak allergy season
- A dedicated Human Factors (HF) study designed to assess usability and patient acceptance of PL-14
- An additional clinical study assessing the nasal residence time of the PL-14 formulation
"Structuring our clinical plan brings us closer to our goal of advancing PL-14 toward regulatory approval and commercialization," Izraeli explained. "By generating strong data around efficacy, safety and user experience, we believe PL-14 can provide meaningful value to millions suffering from allergic rhinitis."
Product Mechanism and Target Market
PL-14 is designed as a mucoadhesive nasal gel spray formulated to act as a physical barrier against airborne allergens. The product is intended to remain in the nasal cavity for approximately 4 hours after application, providing protection without pharmaceutical ingredients.
This approach could offer a novel option for the millions of people worldwide who suffer from seasonal allergic rhinitis, commonly known as hay fever. Current treatments typically include antihistamines, decongestants, and corticosteroids, which may cause side effects or provide insufficient relief for some patients.
Regulatory Path Forward
Following the completion of preclinical work and the upcoming FDA consultation, Polyrizon expects to initiate clinical trials in both the United States and Europe. The company has indicated these trials are likely to begin in late 2025 or early 2026.
The data from the recent safety study will support Polyrizon's regulatory strategy and serve as a key component in discussions during the FDA pre-submission meeting.
As the company advances its development program, it will need to demonstrate not only the safety of PL-14 but also its effectiveness in preventing allergic symptoms under real-world conditions during allergy seasons.
Market Potential
Allergic rhinitis affects approximately 10-30% of adults and up to 40% of children globally, representing a substantial market opportunity for effective interventions. The condition significantly impacts quality of life and productivity, with symptoms including nasal congestion, sneezing, itching, and rhinorrhea.
If successful in its development and regulatory pathway, Polyrizon's PL-14 could potentially offer a non-pharmacological alternative for allergy sufferers seeking options beyond traditional medications.
The company's progress with PL-14 represents a significant step in its mission to develop innovative barrier technologies for respiratory conditions.
