Polyrizon initiates human study for NASARIX allergy blocker
Polyrizon Ltd. (NASDAQ: PLRZ) announced it has executed agreements with a European university medical center and a clinical research organization to conduct a human study evaluating the nasal residence time of its NASARIX allergy blocker.
The study will measure how long the NASARIX formulation remains in the nasal cavity following administration, which the company states is intended to support estimation of the product's potential duration of protective barrier function.
The investigation is structured as a performance and characterization study rather than an interventional clinical trial focused on safety or efficacy. The study forms part of Polyrizon's verification and validation activities and is expected to support the company's regulatory strategy, including planned submissions to the U.S. Food and Drug Administration.
The single-site study will involve healthy participants and utilize repeated measurements over time following administration of the NASARIX formulation. Serial observations, including endoscopic visualization techniques, are designed to provide a temporal profile of product retention within the nasal passages.
"This study is an important step in quantitatively characterizing a core functional property of NASARIX - its residence time in the nasal cavity," said Tomer Izraeli, CEO of Polyrizon. "By understanding how long the formulation remains at the site of action, we can better assess its expected duration of barrier protection."
The study will be conducted according to European regulatory frameworks, including Regulation (EU) 2017/745 and Good Clinical Practice standards. Polyrizon has engaged the clinical research organization to oversee study operations and regulatory processes, enabling the company to initiate submissions to European health authorities and ethics committees for study authorization.
NASARIX is an investigational intranasal hydrogel formulation designed to create a physical barrier in the nasal cavity, potentially preventing allergens from contacting the nasal epithelium.
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