Polyrizon Ltd. (PLRZ), on Thursday, announced the structuring of its clinical strategy for PL-14, a proprietary intranasal allergy blocker for seasonal allergic rhinitis, ahead of its planned pre-submission meeting with the U.S. Food and Drug Administration or FDA.
This strategic update is in preparation for upcoming clinical trials, which will assess PL-14's efficacy and safety under natural exposure conditions during peak allergy season, as well as its usability and patient acceptance through a Human Factors or HF study.
Additionally, a study will evaluate the nasal residence time of the formulation.
Polyrizon plans to initiate clinical trials in the U.S. and Europe between late 2025 and early 2026, following the completion of preclinical work and the FDA consultation.
The company aims to advance PL-14 toward regulatory approval and commercialization, helping millions suffering from allergic rhinitis.
Currently, PLRZ is trading at $0.48 up by 1.05 percent on the Nasdaq.
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