Polyrizon Ltd. Completes GMP Batch Of Clinical Trial Material For Lead Intranasal Product, Paving Way For U.S. Study

Polyrizon Ltd. announced that it has successfully completed the production of a Good Manufacturing Practice (GMP) batch of clinical trial material (CTM) for its lead product candidate. This marks an important achievement for the pre-clinical biotechnology company, which is focused on developing intranasal solutions intended to protect against airborne threats such as allergens and viruses.

This milestone comes after the company’s earlier announcement regarding its manufacturing agreement with Eurofins CDMO AmatsiAquitaine S.A.S. The partnership was established to ensure reliable clinical supply for Polyrizon’s development program, and the successful production of this GMP batch demonstrates the progress made under that collaboration.

Producing the GMP batch represents a significant step forward in Polyrizon’s clinical development plan. It directly supports the company’s preparations for a planned clinical study in the United States later this year. Before this stage, Polyrizon had already completed two development batches, both of which showed strong consistency between batches and maintained product stability over time. These results helped validate the manufacturing process and provided confidence that the product can be produced reliably at clinical scale.

The newly completed CTM batch was manufactured in full compliance with relevant GMP standards, working closely with Eurofins CDMO AmatsiAquitaine S.A.S throughout the process. This material will be used in upcoming clinical activities, including regulatory submissions and requirements associated with the planned U.S. study.

Tomer Izraeli, CEO of Polyrizon, stated that the successful GMP production is an important advancement in the company’s development strategy. He noted that the earlier development batches had already proven the manufacturing process to be consistent and stable, and that the completion of the GMP batch now allows the company to move ahead with its first clinical study in the United States. 

He emphasized the company’s commitment to creating innovative intranasal products aimed at protecting individuals from airborne allergens and viruses. This milestone further reflects Polyrizon’s ongoing progress in advancing its intranasal technology platform. With each step, the company moves closer to delivering new preventive solutions for respiratory conditions and making them accessible to patients who may benefit from them.