Polyrizon Ltd. has completed contracting with all five clinical sites for its NASARIX Allergy Blocker study, marking a critical milestone for the Israeli biotechnology firm. The agreements with the final two sites were finalized this week, completing the network of trial locations required for the first-in-human study.
The planned multicenter, randomized, single-blind, two-arm clinical trial is designed to enroll up to 120 randomized patients, assigned in a 1:1 ratio to receive either the NASARIX Allergy Blocker or an isotonic saline nasal spray control. Patient enrollment is scheduled to align with allergy seasons to evaluate seasonal allergic rhinitis under real-world allergen exposure, with local pollen counts and weather conditions monitored to guide recruitment timing.
The primary efficacy endpoint will assess the difference between treatment groups in mean daily reflective Total Nasal Symptom Score over the first 14 treatment days. Safety assessments include the frequency and severity of treatment-emergent adverse events, alongside local and overall tolerability evaluations. Secondary efficacy measures are expected to include instantaneous Total Nasal Symptom Score, rhinoconjunctivitis-related quality of life, symptom-free days, and the use of permitted relief medication.
NASARIX, designated as PL-14, is a proprietary nasal spray designed to create a protective barrier within the nasal cavity. Polyrizon specializes in the development of intranasal hydrogels, positioning the company at the intersection of allergy treatment innovation and mucosal drug delivery technology.
