Polyrizon finalizes contracts with five U.S. clinical sites for NASARIX™ trial, targeting 120 patient enrollments for allergy research.
Quiver AI Summary
Polyrizon Ltd. has finalized contracts with all five U.S. clinical sites for its NASARIX™ Allergy Blocker study, an important step towards enrolling 120 patients. This first-in-human trial aims to assess the efficacy, safety, and tolerability of NASARIX™ in treating seasonal allergic rhinitis through a multicenter, randomized, single-blind design. Participants will be split evenly to receive either the nasal spray treatment or a saline control, with primary outcomes focusing on changes in daily nasal symptom scores over 14 days. Safety will be monitored alongside secondary measures like quality of life and symptom-free days. With this milestone achieved, Polyrizon is preparing for patient pre-screening and enrollment, coordinating with local pollen counts to align with allergy seasons. The CEO, Tomer Izraeli, emphasizes the study's potential to yield significant clinical evidence to advance NASARIX™ toward the U.S. market.
Potential Positives
- Polyrizon has successfully contracted all five U.S. clinical sites for its NASARIX™ study, marking a significant operational milestone.
- The NASARIX™ study is advancing toward enrollment of 120 patients, indicating progress in clinical trials aimed at addressing seasonal allergic rhinitis.
- The study is designed under real-world conditions, which may enhance the relevance and applicability of the findings regarding NASARIX™.
Potential Negatives
- Completion of contracting with clinical sites may highlight prior delays or challenges in securing these agreements, raising concerns about the efficiency of the company's operational processes.
- The reliance on seasonal allergen exposure for patient enrollment may lead to challenges in timely recruitment and execution of the study, potentially impacting the overall study timeline.
- Forward-looking statements suggest uncertainty regarding the success and outcomes of the clinical study, indicating that management's optimism may not be guaranteed.
FAQ
What is NASARIX™ and how does it work?
NASARIX™ is an innovative nasal spray designed to create a barrier in the nasal cavity, preventing contact with allergens for managing seasonal allergic rhinitis.
How many patients will be enrolled in the NASARIX™ study?
The NASARIX™ study plans to enroll up to 120 patients with seasonal allergic rhinitis for its first-in-human clinical trial.
What are the primary endpoints of the NASARIX™ clinical study?
The primary efficacy endpoint will assess differences in mean daily reflective Total Nasal Symptom Score (rTNSS) between the treatment groups.
What are the plans for patient recruitment in the NASARIX™ study?
Patient recruitment will coincide with relevant allergy seasons, monitoring local pollen counts and weather conditions to assess allergen exposure.
What milestone has Polyrizon achieved in the NASARIX™ study?
Polyrizon has completed contracting with all five U.S. clinical sites, marking a significant operational milestone in the NASARIX™ program.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$PLRZ Insider Trading Activity
$PLRZ insiders have traded $PLRZ stock on the open market 6 times in the past 6 months. Of those trades, 0 have been purchases and 6 have been sales.
Here’s a breakdown of recent trading of $PLRZ stock by insiders over the last 6 months:
- TOMER IZRAELI (Chief Executive Officer) has made 0 purchases and 2 sales selling 4,400 shares for an estimated $48,435.
- OZ ADLER sold 3,292 shares for an estimated $39,668
- TIDHAR TURGEMAN (Chief Technology Officer) sold 2,917 shares for an estimated $31,795
- LIRON CARMEL has made 0 purchases and 2 sales selling 1,042 shares for an estimated $12,743.
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$PLRZ Hedge Fund Activity
We have seen 4 institutional investors add shares of $PLRZ stock to their portfolio, and 6 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- MMCAP INTERNATIONAL INC. SPC added 199,470 shares (+inf%) to their portfolio in Q2 2026, for an estimated $2,497,364
- FNY INVESTMENT ADVISERS, LLC removed 24,575 shares (-100.0%) from their portfolio in Q2 2026, for an estimated $307,679
- HRT FINANCIAL LP added 21,363 shares (+inf%) to their portfolio in Q2 2026, for an estimated $267,464
- JANE STREET GROUP, LLC removed 14,032 shares (-100.0%) from their portfolio in Q1 2026, for an estimated $163,893
- CITADEL ADVISORS LLC removed 10,149 shares (-100.0%) from their portfolio in Q2 2026, for an estimated $127,065
- LEGACY WEALTH MANAGMENT, LLC/ID removed 1,150 shares (-100.0%) from their portfolio in Q2 2026, for an estimated $14,398
- UBS GROUP AG removed 1,025 shares (-100.0%) from their portfolio in Q1 2026, for an estimated $11,972
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Full Release
Polyrizon completes contracting with all five U.S. clinical sites and advances its NASARIX™ study toward enrollment of 120 patients
Raanana, Israel, Aug. 20, 2026 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (the “Company” or “Polyrizon”), a development-stage biotech company specializing in the development of innovative intranasal hydrogels, today 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 now completed the contracting process with all five clinical sites selected to participate in the study, marking an important operational milestone in the advancement of the NASARIX™ clinical program.
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.
“Completing agreements with all five clinical sites is an important step in moving NASARIX™ from clinical preparation toward study execution,” said Tomer Izraeli, Chief Executive Officer of Polyrizon. “With the full clinical site network now in place, our focus shifts to patient pre-screening and readiness for enrollment as seasonal allergen exposure increases. We believe this study has the potential to generate important clinical evidence regarding the efficacy, safety and tolerability of NASARIX™ and represents a significant milestone in our strategy to advance the product toward the U.S. market.”
About NASARIX TM
NASARIX TM 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, patient pre-screening and enrollment activities, the Company's belief that this study has the potential to generate important clinical evidence regarding the efficacy, safety and tolerability of NASARIX™, and the Company's strategy to advance NASARIX™ toward the U.S. market. 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
[email protected]