Core Viewpoint - Polyrizon Ltd. has announced a successful preliminary safety study for its PL-14 Allergy Blocker, marking a significant advancement in the product's development path [1][5]. Group 1: Study Details - The safety study was conducted on fully differentiated human nasal tissue using the MucilAir™ model, demonstrating strong local tolerability [2]. - The study assessed local tolerance and tissue response after a 4-hour application of PL-14, a mucoadhesive nasal gel spray designed to act as a physical barrier against airborne allergens [3]. - Key safety indicators evaluated included tissue integrity (TEER), cytotoxicity (LDH), cilia beating frequency (CBF), mucociliary clearance (MCC), and inflammatory response (IL-8 secretion), with results showing no signs of inflammatory activation or functional impairment [4]. Group 2: Regulatory and Development Plans - The results of the study are a milestone in validating the local safety of PL-14 and support the company's clinical development plans [5]. - The data will aid in the regulatory strategy and support an upcoming FDA pre-submission meeting, with U.S. and European clinical trials expected to begin in late 2025 or early 2026 [6]. Group 3: Company Overview - Polyrizon is a development stage biotech company focused on innovative medical device hydrogels delivered as nasal sprays, which create a barrier against viruses and allergens [7]. - The company is developing its proprietary Capture and Contain (C&C) hydrogel technology, which aims to enhance bioadhesion and prolonged retention for intranasal drug delivery [7].
Polyrizon Reports Successful Safety Study of a Formulation of PL-14 Allergy Blocker in Human Nasal Tissue Model