Polyrizon completes biocompatibility tests for NASARIX nasal spray

Polyrizon Ltd. (Nasdaq: PLRZ), an Israel-based development-stage biotech company, announced that its NASARIX™ Allergy Blocker nasal spray has completed a biocompatibility evaluation program, with all required biological safety tests meeting predetermined acceptance criteria.

The evaluation program was designed in accordance with ISO 10993 standards, FDA guidance, and European regulatory requirements. Testing covered cytotoxicity, sensitization, irritation and intracutaneous reactivity, material-mediated pyrogenicity, and acute systemic toxicity. Long-term systemic toxicity was assessed through a toxicological risk assessment conducted under ISO 10993-17.

The evaluation was based on the final NASARIX™ product configuration and incorporated assessments of formulation components, manufacturing processes, packaging materials, and intended patient exposure.

NASARIX™ is a drug-free mucoadhesive nasal spray designed to create a protective barrier within the nasal cavity intended to reduce contact between inhaled allergens and nasal mucosa. It is being developed for the management of seasonal allergic rhinitis.

"Achieving positive results across all required biological safety assessments represents a significant milestone in our development program and further supports the biocompatibility safety profile of NASARIX™ as we continue advancing its clinical and regulatory pathway," said Tomer Izraeli, CEO of Polyrizon.

The company said the completed program strengthens the non-clinical package supporting NASARIX™ as it advances toward a first-in-human clinical trial, according to the press release.

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