Polyrizon Completes All Five U.S. Site Contracts for NASARIX™ First-in-Human Allergy Study
Polyrizon (PLRZ) has completed contracting with all five U.S. clinical sites for its first-in-human study of NASARIX™ Allergy Blocker (PL-14), advancing the program into study execution.
Rhea-AI Summary
Polyrizon (PLRZ) has completed contracting with all five U.S. clinical sites for its first-in-human study of NASARIX™ Allergy Blocker (PL-14), advancing the program into study execution.
The prospective, multicenter, randomized, single-blind, two-arm trial in seasonal allergic rhinitis will enroll up to 120 patients, randomized 1:1 to receive NASARIX or an isotonic saline nasal spray control. The primary efficacy endpoint is the difference between treatment groups in mean daily reflective Total Nasal Symptom Score (rTNSS) over the first 14 treatment days, with safety assessed via treatment-emergent adverse events and local/overall tolerability. Secondary measures are expected to include instantaneous TNSS (iTNSS), quality of life, symptom-free days, and use of permitted relief medication. Enrollment is planned to align with relevant allergy seasons, using local pollen counts and weather conditions to guide recruitment timing.
Positive
- All five U.S. clinical site contracts completed, enabling NASARIX™ first-in-human study execution
- Planned trial to enroll up to 120 patients in randomized, controlled design
- Clearly defined primary endpoint using rTNSS over 14 treatment days
Negative
- None.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Aug 20 | Clinical site contracting | Positive | -1.7% | Completed five-site network and advanced NASARIX toward patient enrollment |
| Jul 02 | Biocompatibility results | Positive | +8.8% | Required biological safety tests met predefined acceptance criteria |
| Jun 29 | Clinical trial approval | Positive | +11.1% | Central IRB approval enabled the first human NASARIX clinical trial |
| Jun 17 | Patent application publication | Positive | +15.6% | U.S. patent application publication covered the mucoadhesive drug delivery platform |
| Jun 15 | Human performance study | Positive | -2.7% | Study agreements supported NASARIX residence-time characterization |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Prior positive NASARIX and platform milestones produced mixed reactions, with both aligned gains and divergent declines.
Key Terms
intranasal hydrogels technical
treatment-emergent adverse events medical
bioadhesion technical
active pharmaceutical ingredients technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Raanana, Israel, Sept. 02, 2026 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (the “Company” or “Polyrizon”), a development-stage biotech company specializing in the development of innovative intranasal hydrogels, recently announced that it has completed contracting with the fourth and fifth clinical sites participating in its clinical study of NASARIX™ Allergy Blocker (PL-14).
With the execution of these final agreements, Polyrizon has completed the contracting with all five U.S. clinical sites selected for the study, marking an important operational milestone and moves the NASARIX™ program into study execution. The planned first-in-human study is a prospective, multicenter, randomized, single-blind, two-arm clinical trial designed to evaluate the efficacy, safety and tolerability of NASARIX™ in patients with seasonal allergic rhinitis. The study is designed to enroll up to 120 randomized patients, with subjects assigned in a 1:1 ratio to receive either NASARIX™ Allergy Blocker or an isotonic saline nasal spray control.
The study’s primary efficacy endpoint will evaluate the difference between the treatment groups in mean daily reflective Total Nasal Symptom Score (rTNSS) over the first 14 treatment days. Safety assessments will include the frequency and severity of treatment-emergent adverse events as well as assessments of local and overall tolerability.
Secondary efficacy measures are expected to include instantaneous Total Nasal Symptom Score (iTNSS), rhinoconjunctivitis-related quality of life, the number of symptom-free days, and use of permitted relief medication.
Following completion of the clinical site contracting process, Polyrizon is advancing the study into the next stage of execution, including patient pre-screening activities and preparations for enrollment. Because the study evaluates seasonal allergic rhinitis under real-world allergen exposure conditions, patient enrollment is planned to coincide with the relevant allergy seasons. Local pollen counts and weather conditions will be monitored to assess airborne allergen exposure and support the timing of recruitment.
About NASARIXTM
NASARIXTM is Polyrizon’s proprietary nasal spray designed to create a protective barrier within the nasal cavity, helping to prevent contact between inhaled allergens and the nasal mucosa. The product is being developed as a non-drug approach for the management of seasonal allergic rhinitis.
About Polyrizon
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 the timing and progress of its NASARIX™ clinical study and patient pre-screening and enrollment activities. 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 on Form 20-F for the fiscal year ended December 31, 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
