Polyrizon Ltd (NASDAQ:PLRZ) reported a notable market reaction after announcing the initiation of a human study to measure the nasal residence time of NASARIX, its investigational intranasal hydrogel. Shares of the company rose 9.2% on Monday following the announcement.
The company said it formalized an arrangement with a European university medical center and a clinical research organization to run a human performance and characterization study. The investigation will focus on how long NASARIX remains within the nasal cavity after administration, a parameter the company identifies as central to the product’s barrier-protection function.
Polyrizon framed the study as part of its broader verification and validation program, stating the data collected are expected to contribute to the company’s regulatory strategy, which includes planned future submissions to the U.S. Food and Drug Administration.
The protocol will be executed in line with applicable European regulatory frameworks, explicitly including Regulation (EU) 2017/745, as well as Good Clinical Practice standards. The chosen university medical center specializes in otolaryngology and clinical research and has specific expertise in nasal physiology and advanced imaging methodologies, according to the company.
The single-site study will recruit healthy participants and will rely on repeated measurements over time to construct a temporal retention profile for NASARIX. Endoscopic visualization techniques will be employed among the measurement tools to directly observe product retention within the nasal passages.
Polyrizon’s CEO, Tomer Izraeli, described the study as an important quantitative step: "This study is an important step in quantitatively characterizing a core functional property of NASARIX - its residence time in the nasal cavity," he said. "By understanding how long the formulation remains at the site of action, we can better assess its expected duration of barrier protection."
NASARIX is being developed as an intranasal hydrogel intended to create a physical barrier inside the nasal cavity, with the objective of preventing allergens from making contact with the nasal epithelium. The study’s focus on residence time directly targets this functional characteristic, which the company views as indicative of potential protective duration.
By aligning the trial with European regulatory standards and Good Clinical Practice, Polyrizon indicated the data will be collected under conditions intended to be compatible with regulatory review. The single-site, healthy-participant design and the use of serial endoscopic assessments are central elements of the company’s plan to produce a temporal profile of retention.
Investors reacted to the study’s commencement, sending the stock higher, while the company pursues verification, validation and regulatory steps intended to inform future submissions to regulatory authorities.