Announcement • May 15
Polyrizon Advances Towards Human Clinical Trials: Secures First U.S. Clinical Site for NASARIX™ Allergy Blocker Clinical Trial Polyrizon Ltd. had announced the signing of its first Clinical Trial Agreement (CTA) with a U.S.-based clinical research site specializing in allergy studies, marking a key milestone toward the initiation of its clinical program for the NASARIXTM (PL-14) Allergy Blocker. The clinical site, located in Texas, will serve as the first participating center in Polyrizon’s planned multi-center study evaluating the safety, tolerability, and efficacy of the NASARIXTM Allergy Blocker in patients with seasonal allergic rhinitis. The clinical study, titled “Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients with Seasonal Allergic Rhinitis”, will assess the performance of Polyrizon’s investigational nasal spray designed to create a protective barrier against airborne allergens. The study is planned as a multi-center trial, with additional clinical sites expected to be added in the coming months. The trial will be conducted in accordance with international Good Clinical Practice (GCP) standards and applicable regulatory requirements, supporting Polyrizon’s broader regulatory strategy. NASARIXTM is an investigational intranasal formulation designed to provide a non-pharmacological barrier against allergens, with the goal of preventing allergic reactions at the point of entry. Announcement • May 05
Polyrizon Ltd Submits Amended Claims In U S Patent Application For Intranasal Drug Delivery Platform Polyrizon Ltd. announced the submission of amended claims in its U.S. patent application for its proprietary intranasal drug delivery platform. The amended claims expand the scope of protection of the Company’s technology to include not only the core mucoadhesive composition, but also drug delivery systems and methods of use, which are designed to enhance the effectiveness of medications by increasing their residence time and ensuring close contact with mucosal tissues. The expanded claims relate to compositions comprising sulfated polysaccharide polymers and additional polymeric components that form a uniform and continuous film upon contact with epithelial mucosa, enabling improved delivery of active pharmaceutical ingredients (APIs). Key Potential Features of the Platform: · Prolonged Residence Time: Enhancing the duration that drugs remain at the site of administration, supporting improved absorption and efficacy. · Improved Bioavailability: Increasing the effectiveness of APIs through enhanced mucosal interaction and retention. · Controlled Film Formation: Transformation into a uniform, continuous film upon contact with mucosal surfaces. · Versatility: Compatibility with a wide range of drug types and therapeutic indications. The Company’s platform leverages the unique properties of intranasal delivery to facilitate both local and systemic administration of drugs. By enhancing retention and interaction with mucosal tissues, the technology has the potential to improve treatment outcomes across multiple indications. 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 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. Announcement • Apr 28
Polyrizon Ltd Announces Filing of European Patent Application for Trap and Target Platform Technology Polyrizon Ltd, a development-stage biotech company specializing in the development of innovative intranasal hydrogels, announced the filing of a divisional patent application with the Europe Patent Office for its Trap & Target (T&T) platform technology. This application focuses exclusively on protecting the Company’s advanced intranasal drug delivery system, which is designed to enhance the effectiveness of medications by increasing their residence time and ensuring close contact with mucosal tissues and aligns with the Company’s recently announced U.S. patent application which encompasses key aspects of Polyrizon’s two core platform technologies: Capture and Contain (C&C™), a nasal blocker technology, and Trap and Target (T&T™), designed for advanced nasal drug delivery. The T&T platform represents a significant advancement in intranasal drug delivery, offering a novel approach to improving the bioavailability of active pharmaceutical ingredients (APIs) and addressing critical challenges in both local and systemic drug delivery. The divisional patent application underscores Polyrizon’s commitment to securing comprehensive intellectual property protection for its innovative technology, which aim to revolutionize respiratory health and drug delivery. Key Potential Features of the Trap & Target (T&T) Platform: Prolonged Residence Time: Enhancing the duration that drugs remain at the nasal absorption site, facilitating better absorption and efficacy. Improved Bioavailability: Increasing the amount of drug that reaches systemic circulation by bypassing first-pass metabolism and potentially improving therapeutic outcomes. Controlled Release: Allows for precise management of API release kinetics to ensure optimal therapeutic levels over time. Prevention of Dripping: The system is designed to prevent the formulation from dripping out of the nasal cavity to ensure maximum efficacy and patient comfort. Biodegradable Components: Utilizing safe and environmentally friendly biodegradable polymers. Versatility: Compatibility with a wide range of drug types, including small molecules, proteins, peptides, and antibodies, making it suitable for diverse therapeutic applications. The T&T platform leverages the nasal cavity’s rich vascularization to facilitate both local and systemic drug delivery, offering a promising solution for various therapeutic applications, such as corticosteroids for allergic rhinitis, benzodiazepines for epileptic seizures and naloxone for opioid overdose. By enhancing drug absorption and bioavailability, the platform has the potential to improve the treatment of respiratory conditions, central nervous system disorders, and other medical needs. This application aligns with the Company’s recently announced U.S. patent application which encompasses key aspects of Polyrizon’s two core platform technologies: Capture and Contain (C&C™) and Trap and Target (T&T). The Capture and Contain (C&C™) platform utilizes a natural 3D polymeric network engineered to adhere optimally to the nasal mucosa. This advanced network forms a physical barrier that captures and contains airborne biological threats, such as allergens, viruses (such as Influenza), and molds, preventing their penetration and protecting the body. 
