Jan 23, 2026
Ontario, Canada – January 19, 2026– Pleryon Therapeutics (“Pleryon”), a biotechnology company developing innovative polymer-based therapeutics for diseases with high unmet clinical needs, today announced that Health Canada has granted an Investigational Testing Authorization (ITA) for the first-in-human (FIH) clinical trial of P002.
P002 is an investigational eye drop containing a lubricin-inspired diblock copolymer developed by Pleryon to provide long-lasting boundary lubrication at the ocular surface. The clinical trial will be conducted at the Centre for Ocular Research & Education (CORE) at the University of Waterloo, primarily evaluating the safety and tolerability of P002. Preliminary efficacy of P002 in patients with dry eye disease will also be assessed.
“We are delighted to receive Pleryon's first clinical trial authorization at the beginning of 2026.” said Dr. Yu Yu, founder and CEO of Pleryon Therapeutics. "This is a significant milestone for Pleryon's transition into a clinical-stage biotechnology company, and in advancing our global clinical development strategy. We look forward to evaluating P002's potential to address an important unmet need for dry eye patients worldwide.
Dr. Charis Lau, Chief Medical Officer of Pleryon Therapeutics, added: "CORE holds an outstanding reputation in ocular surface disease research. With regulatory and ethics approvals in place, we will initiate the study and begin enrollment activities in the coming months. We look forward to collaborating with CORE to advance the development of this novel therapy."
About Dry Eye Disease and P002
Dry eye disease is a major global unmet need, impacting over 300 million patients. Existing therapies had significant limitations including low patient satisfaction rate, highlighting the urgent demand for more effective options. The global dry eye market exceeds $5 billion, reflecting its substantial demand for innovation.
P002 is an investigational synthetic polymer-based eye drop inspired by the structure of the natural glycoprotein lubricin, which is found on the ocular surface and in synovial joint fluid. Leveraging Pleryon’s proprietary polymer engineering platform, P002 is designed to mimic the core structure and function of natural lubricin, providing long-acting boundary lubrication and protection to the ocular surface. Preclinical studies have demonstrated favorable and supportive safety profiles across multiple in vitro and in vivo models. Furthermore, the manufacturing process is robust and readily scalable to support late-stage development and commercialization.
About Pleryon Therapeutics
Pleryon Therapeutics is a biotechnology company dedicated to addressing high unmet medical needs through a pioneering polymer engineering platform. The company is developing first-in-class polymer-based therapeutics for conditions such as osteoarthritis and dry eye disease. With a team of industry veterans and a global network of partners, Pleryon plans to initiate first-in-human clinical trials for its lead programs in 2026. Pleryon is backed by leading life science investors, including Lapam Capital and Efung Capital.
Forward-Looking Statements
This press release contains forward-looking statements, including those regarding the development, safety, efficacy, and potential benefits of P002 and the timing of clinical trials. Actual results may differ materially due to risks and uncertainties inherent in pharmaceutical product development. Pleryon undertakes no obligation to update these statements except as required by law.
Media Contact
Pleryon Therapeutics www.pleryon.com