Polyrizon Structures Clinical Strategy for its Allergy Blocker Ahead of FDA Pre-Submission Meeting
Polyrizon Ltd. recenytly 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 USFDA, 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 (HF) 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.
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.”
Polyrizon expects to initiate clinical trials in the US and Europe in late 2025 to early 2026, following the completion of preclinical work and the upcoming FDA consultation.
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 hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target, or T&T. For more information, please visit https://polyrizon-biotech.com.
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