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Polyrizon Structures Clinical Strategy for its Allergy Blocker Ahead of FDA Pre-Submission Meeting
Studies to assess efficacy, safety, user experience, and nasal residence time as Company prepares for regulatory path forward Raanana, Israel, March 27, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ), a biotech company specializing in innovative intranasal hydrogels, today announced the structuring of its clinical strategy for PL-14, the Company’s proprietary intranasal allergy blocker for seasonal allergic rhinitis. The clinical strategy was updated in preparation for a planned pre-subm
About this update from Polyrizon Ltd.
[{"type":"text","content":"Studies to assess efficacy, safety, user experience, and nasal residence time as Company prepares for regulatory path forward","length":125,"tagName":"p"},{"type":"text","content":"Raanana, Israel, March 27, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ), a biotech company specializing in innovative intranasal hydrogels, today announced the structuring of its clinical strategy for PL-14, the Company’s proprietary intranasal allergy blocker for seasonal allergic rhinitis.","length":303,"tagName":"p"},{"type":"text","content":"The clinical strategy was updated in preparation for a planned pre-submission meeting with the U.S. Food and Drug Administration (FDA), which is expected to be followed by the initiation of clinical trials.","length":206,"tagName":"p"},{"type":"text","content":"The comprehensive clinical studies is expected to include:","length":58,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"A clinical study evaluating efficacy and safety under natural exposure conditions during peak allergy season","length":108,"tagName":"p"}]},{"val":[{"type":"text","content":"A dedicated Human Factors (HF) study designed to assess usability and patient acceptance of PL-14","length":97,"tagName":"p"}]},{"val":[{"type":"text","content":"An additional clinical study assessing the nasal residence time of the PL-14 formulation.","length":89,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":294,"olType":false},{"type":"text","content":"Tomer Izraeli, CEO of Polyrizon, said: “Structuring our clinical plan brings us closer to our goal of advancing PL-14 toward regulatory approval and commercialization. By generating strong data around efficacy, safety and user experience, we believe PL-14 can provide meaningful value to millions suffering from allergic rhinitis.”","length":331,"tagName":"p"},{"type":"text","content":"Polyrizon expects to initiate clinical trials in the U.S. and Europe in late 2025 to early 2026, following the completion of preclinical work and the upcoming FDA consultation.","length":176,"tagName":"p"},{"type":"text","content":"About Polyrizon Ltd.","length":20,"tagName":"p"},{"type":"text","content":"Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrog...