Announcement • Jul 02
Polyrizon Announces Successful Results For NASARIX Biocompatibility Program Supporting Advancement Towards First In Human Clinical Trial Polyrizon Ltd. announced successful results from its biocompatibility evaluation program for its proprietary NASARIX Allergy Blocker nasal spray, with all required biological safety tests meeting their predetermined acceptance criteria. The comprehensive evaluation program was designed in accordance with internationally recognized standards for biological safety assessment of medical devices, including the ISO 10993 series, FDA guidance, and applicable European regulatory requirements. The program was developed to assess the safety and biocompatibility profile of NASARIX, a drug-free mucoadhesive nasal spray intended to help reduce exposure to airborne allergens associated with seasonal allergic rhinitis. The completed testing program evaluated key biological safety endpoints identified for the device, including: Cytotoxicity, Sensitization, Irritation /Intracutaneous Reactivity, Material-Mediated Pyrogenicity, Acute Systemic Toxicity. In addition, long-term systemic toxicity was assessed through a toxicological risk assessment conducted in accordance with ISO 10993-17, demonstrating substantial safety margins across the product’s constituent materials under intended conditions of use. The biocompatibility evaluation was based on the final NASARIX product configuration and supported by extensive toxicological assessments of the formulation components, manufacturing processes, packaging materials, and intended patient exposure. According to the Biological Evaluation Plan, the product consists of well-characterized materials with established safety profiles and utilizes a manufacturing process designed to minimize biological risk. The biocompatibility evaluation program was developed under a risk-management framework consistent with ISO 10993-1 and ISO 14971 and included assessment of physical and chemical characteristics, material safety data, toxicological literature, manufacturing controls, and endpoint-specific biological testing. The successful completion of the biocompatibility program further strengthens the non-clinical package supporting NASARIX and represents an important step toward potential commercialization of the product as a novel nasal barrier technology designed to help individuals suffering from seasonal allergies. NASARIX 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. PLRZ
Live News • Jul 01
Polyrizon Cleared to Begin First Human Trial for Nasarix Allergy Nasal Spray Polyrizon received Central IRB approval from the BRANY Institutional Review Board to begin its first human clinical trial of NASARIX™, a nasal spray intended to block airborne allergens in patients with seasonal allergic rhinitis, clearing the study protocol, consent forms and trial materials on ethical and participant protection grounds.
The trial will compare the efficacy, safety and tolerability of NASARIX™ against a saline spray, representing a key step toward gathering initial human data on the product and advancing Polyrizon’s pipeline beyond preclinical work.
Polyrizon’s stock trades at US$12.52, with the share price down 27.1% over the past 30 days, indicating that the clinical milestone follows a recent period of weaker share performance.
This IRB approval moves Polyrizon from planning into execution on NASARIX™, and the upcoming human data now represents a central risk and potential catalyst, because future regulatory and commercial progress will depend heavily on the results of this first trial. Announcement • Jun 30
Polyrizon Receives Central Irb Approval for Its Allergy Blocker Clinical Trial Polyrizon Ltd. announced it has received central IRB approval to begin its first human clinical trial for NASARIX™, the Company’s innovative nasal spray designed to block airborne allergens. This approval from BRANY Institutional Review Board (granted June 18, 2026) is a key regulatory milestone for the Company. It confirms that the study protocol, patient consent forms, and trial materials have been reviewed and approved by the central IRB and satisfy applicable ethical and participant protection requirements. The approved study, titled “Evaluation of the Efficacy, Safety, and Tolerability of NASARIXTM Allergy Blocker Compared to Saline Spray in Patients with Seasonal Allergic Rhinitis,” is designed to assess the efficacy, safety, and tolerability of NASARIXTM in patients suffering from seasonal allergic rhinitis. The study will compare NASARIXTM against a saline spray control to evaluate symptom relief and overall patient outcomes. The IRB reviewed and approved the clinical protocol (PL14-CTP-01), associated instructions for use, informed consent documents, quality-of-life assessments, and electronic diary tools that will be used during the study. The BRANY approval applies to the study’s master protocol and supporting documentation. Individual clinical sites must obtain separate site-specific approvals before initiating study-related activities or enrolling participants. The approval remains valid through June 17, 2027, subject to ongoing IRB oversight and regulatory compliance requirements. 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. 
