Polyrizon has completed agreements with five sites for its planned clinical trial evaluating Nasarix Allergy Blocker (PL-14) in patients with seasonal allergic rhinitis.
This step marks the end of the contracting process for the selected trial locations and initiates the next phase of the study’s preparation.
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The two-arm, single-blind, randomised, multi-centre trial will be the first human study of Nasarix, a spray being developed to manage seasonal allergic rhinitis through a hydrogel barrier in the nasal cavity.
It is set to enrol up to 120 patients. Participants will be assigned in equal numbers to Nasarix or a control group receiving isotonic saline nasal spray.
The main efficacy measure is the difference in mean daily reflective Total Nasal Symptom Score (rTNSS) between the treatment arms over the first 14 treatment days.
Safety will be tracked by monitoring the frequency and severity of treatment-emergent adverse events and evaluating local and overall tolerability.
Secondary endpoints include instantaneous Total Nasal Symptom Score (iTNSS), impact on quality of life related to rhinoconjunctivitis, symptom-free days, and the use of relief medication.
With all sites contracted, Polyrizon is now progressing to patient pre-screening and final preparations for recruitment.
Enrolment will be timed to coincide with allergy seasons, with local pollen levels and weather conditions being monitored to assess allergen exposure and support scheduling.
Polyrizon CEO Tomer Izraeli said: “Completing agreements with all five clinical sites is an important step in moving Nasarix from clinical preparation toward study execution.
“We believe this study has the potential to generate important clinical evidence regarding the efficacy, safety and tolerability of Nasarix and represents a significant milestone in our strategy to advance the product toward the US market.”
Polyrizon is developing Nasarix as a non-drug option for blocking contact between airborne allergens and nasal tissues.
