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Polyrizon Structures Clinical Strategy for its Allergy Blocker Ahead of FDA Pre-Submission Meeting
Globenewswireยท 2025-03-27 12:25
Core Insights - Polyrizon Ltd. is advancing its clinical strategy for PL-14, an intranasal allergy blocker aimed at treating seasonal allergic rhinitis, in preparation for regulatory approval and commercialization [1][2][3] Clinical Strategy - The company is structuring its clinical plan to support a pre-submission meeting with the U.S. FDA, which will be followed by the initiation of clinical trials [2] - Comprehensive clinical studies will assess efficacy, safety, user experience, and nasal residence time of PL-14 [5] Clinical Trials Timeline - Polyrizon expects to begin clinical trials in the U.S. and Europe between late 2025 and early 2026, after completing preclinical work and the upcoming FDA consultation [2] Product Technology - Polyrizon specializes in innovative medical device hydrogels delivered as nasal sprays, which create a barrier against viruses and allergens in the nasal cavity [3] - The proprietary Capture and Contain (C&C) hydrogel technology is designed to function as a "biological mask" [3] Additional Development - The company is also developing the Trap and Target (T&T) technology for nasal delivery of active pharmaceutical ingredients, which is currently in pre-clinical development [3]