Polyrizon (PLRZ) 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-submission meeting with the U.S. Food and Drug Administration, which is expected to be followed by the initiation of clinical trials. The comprehensive clinical studies is expected to include: A clinical study evaluating efficacy and safety under natural exposure conditions during peak allergy season; A dedicated Human Factors study designed to assess usability and patient acceptance of PL-14; An additional clinical study assessing the nasal residence time of the PL-14 formulation. 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.
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