Polyrizon Ltd. (NASDAQ:PLRZ) ("Polyrizon" or the "Company"), a pre-clinical-stage biotechnology company developing intranasal administrated solutions, today announced the successful production of a Good Manufacturing Practice (GMP) batch of clinical trial material (CTM) for its lead product candidate.
This milestone follows the Company's previously announced manufacturing agreement with Eurofins CDMO AmatsiAquitaine S.A.S, a leading global GMP CDMO, established to support the supply of clinical trial material for Polyrizon's clinical development program.
The GMP manufacturing milestone represents a key step in Polyrizon's clinical development program and supports the company's preparations for a planned clinical study in the United States later this year.
The GMP batch was manufactured following the successful production of two prior development batches, which demonstrated batch-to-batch consistency and product stability over time, supporting the robustness and reproducibility of the manufacturing process.
The CTM batch was produced in compliance with applicable GMP standards in collaboration with Eurofins CDMO AmatsiAquitaine S.A.S, and will be used to support upcoming clinical activities and regulatory submissions related to the study.
This milestone reflects Polyrizon's continued progress toward advancing its intranasal technology platform and bringing novel preventive solutions for respiratory conditions closer to patients.