NASARIX achieves positive biological safety results
Shares of Polyrizon Ltd. (NASDAQ:PLRZ) gained 10% on Friday after the biotechnology company reported successful results from the biocompatibility evaluation programme for its NASARIX Allergy Blocker nasal spray.
According to the company, all required biological safety assessments met their predefined acceptance criteria, marking another step forward in the product’s development.
Testing completed under international regulatory standards
Polyrizon said the evaluation programme was conducted in line with internationally recognised biological safety standards for medical devices, including the ISO 10993 series, U.S. Food and Drug Administration guidance and relevant European regulatory requirements.
The assessment covered a range of biological safety endpoints for the drug-free, mucoadhesive nasal spray, including cytotoxicity, sensitisation, irritation, material-mediated pyrogenicity and acute systemic toxicity.
Long-term systemic toxicity was evaluated through a toxicological risk assessment performed in accordance with ISO 10993-17.
Assessment based on final product configuration
The company said the biocompatibility review was carried out using the final NASARIX product configuration and incorporated evaluations of the formulation, manufacturing process, packaging materials and anticipated patient exposure.
“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, Chief Executive Officer of Polyrizon.
Milestone supports path toward commercialisation
Polyrizon noted that the programme was developed within a risk management framework consistent with ISO 10993-1 and ISO 14971.
The successful completion of the evaluation supports the continued clinical and regulatory development of NASARIX as the company works toward the potential commercial launch of its nasal barrier technology for people with seasonal allergies.