Aug 28, 2026
SYDNEY, AUSTRALIA – August 28, 2026 – Pleryon Therapeutics (“Pleryon”), a biotechnology company developing innovative polymer-based technologies for diseases with high unmet clinical need, today announced that it has completed the notification requirements under Australia’s Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) scheme, enabling the company to proceed with the first-in-human (FIH) clinical trial of its lubricin-inspired polymer in osteoarthritis (OA). The study will be conducted at the Royal North Shore Hospital in Sydney, with Professor David Hunter as the principal investigator. It will primarily evaluate the safety and tolerability of a single intra-articular injection in adults with knee OA, with secondary assessments of clinical performance.
OA affects over 500 million people worldwide and remains a leading cause of disability in older adults. Despite its substantial burden on individuals and health systems, innovation in OA has lagged. The investigational product is a first-in-class intra-articular injectable designed to tackle the underlying mechanical drivers of the disease. Leveraging its proprietary polymer platform. Pleryon has engineered a novel diblock copolymer inspired by the structure of lubricin, a key lubricating protein found on the cartilage surface and in the synovial fluid of the joint, to restore boundary lubrication at the cartilage surface. In preclinical studies, the lubricin-inspired polymer has demonstrated greater lubricity than native lubricin, and showed favorable safety profile across multiple in vitro and in vivo models. It aims to reduce pain in patients with knee OA.
“People living with knee OA have limited options between analgesics and joint replacement.”, said Dr. Charis Lau, Chief Medical Officer of Pleryon Therapeutics,” This study will generate the first human data on how the polymer behaves within the joint. We look forward to partnering with Professor Hunter, a world-leading expert in OA, and his team to work on this important study.”
“Receiving TGA notification for our second clinical program marks another transformative milestone for Pleryon as we continue to execute our strategy across multiple areas of high unmet need,” said Dr. Yu Yu, Founder and CEO of Pleryon Therapeutics. “We look forward to working with partners worldwide to bring this new treatment options for patients.”
About Pleryon Therapeutics
Pleryon Therapeutics is a clinical-stage biotechnology company dedicated to addressing high unmet medical need through a pioneering polymer engineering platform. The company is developing polymer-based technologies for conditions including dry eye disease and osteoarthritis. Pleryon is backed by leading life science investors, including Lapam Capital, Kaitai 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 the investigational device 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.
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