[Professor Sei Kwang Hahn’s research team at POSTECH and Shinpoong Pharmaceutical obtain approval for Phase 3 clinical trial]

An increasing number of patients are suffering from knee pain when going up or down the stairs or from swelling and numbness in their knuckles. This is a common symptom of degenerative arthritis caused by the wear and tear of soft cartilage that acts as a buffer between joints. For such osteoarthritis, cartilage strengtheners like analgesics, anti-inflammatory drugs, and steroids are often prescribed to reduce the pain, but they are only temporary measures and do not treat the underlying problem. Recently, POSTECH and Shinpoong Pharmaceutical Co., Ltd. have developed a treatment for osteoarthritis that reduces symptoms and even treats them for more than a year with one single injection, acquiring the approval for a Phase 3 clinical trial.

A research team led by Professor Sei Kwang Hahn in the Department of Materials Science and Engineering at POSTECH – through joint research with Shinpoong Pharmaceutical – has developed a hyaluronic acid hydrogel, an osteoarthritis treatment in which the rate of degradation is controlled in the body. According to the results of animal experiments and Phase 1 clinical trials, this treatment was shown to significantly improve osteoarthritis symptoms by remaining in the joint without degradation for more than a year.

The number of osteoarthritis patients is increasing caused by cartilage damage due to genetic factors, obesity, joint trauma, and inflammation. In the meantime, several types of hyaluronic acid treatment for osteoarthritis have been developed, but once administered, it dissolves rapidly in the body reducing its therapeutic effects.

To this, the research team focused on the fact that the carboxyl group (-COOH) of hyaluronic acid is directly involved when hyaluronic acid binds to hyaluronidase or a receptor in the cell membrane. The researchers used hexamethylene diamine as a crosslinking agent to form a hydrogel in which the carboxyl group of hyaluronic acid was crosslinked. This hydrogel is not easily degraded and remains in the joint area, degrading slowly over a year. In particular, hexamethylene diamine used as a crosslinking agent can be electrostatically bound to the carboxyl group of hyaluronic acid, so it is suitable for use in the body and exhibits excellent safety.

The technology to control the degradation rate of hyaluronic acid hydrogel developed in this study has been granted patents in Korea, the United States, Canada, and Japan.

“Hyaluronic acid is a biopolymer with the best biocompatibility and safety among various biomedical materials. It has a wide range of applications including as fillers for arthritis treatment and plastic surgery, thickener for ophthalmic surgery, post-surgery adhesion barrier, drug delivery system, tissue engineering, and raw material for cosmetics,” explained Professor Hahn who led the study. “Using the technology to control the degradation rate of hyaluronic acid hydrogel, we plan to successfully finish the Phase 3 clinical trial and commercially launch it as an innovative osteoarthritis treatment.”