Polyrizon Ltd. (NASDAQ: PLRZ) has enrolled the first patient in a U.S. clinical trial evaluating its investigational product NASARIX, also referred to as PL-14, marking the company’s transition to a clinical-stage biotech firm.
The prospective, multicenter, randomized, single-blind, two-arm study will enroll 120 patients across five clinical sites in the United States. Participants are randomized 1:1 to receive either the NASARIX Allergy Blocker or a saline nasal spray comparator. The trial evaluates the product for adults with seasonal allergic rhinitis.
The primary efficacy endpoint assesses the difference in mean daily reflective Total Nasal Symptom Score between PL-14 and the saline comparator over the first 14 treatment days. Safety assessments will include the frequency and severity of treatment-emergent adverse events, along with local and overall tolerability evaluations.
NASARIX is a non-pharmacological, drug-free, mucoadhesive hydrogel nasal spray engineered to form a physical barrier within the nasal cavity, reducing contact between inhaled airborne allergens and the nasal mucosa. Polyrizon specializes in medical device hydrogels delivered as nasal sprays using naturally occurring building blocks.
Tomer Izraeli, CEO of Polyrizon, said in a statement: "The enrollment of the first patient in our U.S. study represents the culmination of extensive product development, preclinical evaluation, manufacturing and regulatory preparation."
The company is headquartered in Raanana, Israel.
