Huonslab's HLB3-002 approved for clinical trials

Huonslab's HLB3-002, a genetic recombinant hyaluronidase candidate, has been approved for clinical trials, with potential applications in cosmetic procedures, dermatology, pain and edema treatment.

Huonslab, a research subsidiary of the biopharmaceutical firm Huons Global, is on the brink of commercializing its human genetic recombinant hyaluronidase candidate, HLB3-002, after receiving the Ministry of Food and Drug Safety's approval to begin clinical trials.

The investigational new drug trial will assess the safety and tolerability of a single subcutaneous injection of HLB3-002 in 243 healthy adults. It will take place at four prominent medical institutions in Korea: Seoul National University Hospital, Asan Medical Center, Konkuk University Medical Center and Chung-Ang University Hospital.

Studies on animals comparing HLB3-002 with Hylenex, a product from the U.S.-based biotechnology company Halozyme Therapeutics, have indicated that the two drugs have equivalent efficacy. Nonclinical toxicity tests have also spoken for the recombinant hyaluronidase candidate's safety.

The recently approved trial is a pivotal step toward product approval, which Huonslab plans to apply for by next June pending the results of the upcoming trials.

Huonslab completed domestic patent registration for the product's manufacturing method last July and is now pursuing international patent applications. The company expects that HLB3-002 will lead to fewer side effects, such as allergies, than existing animal-derived hyaluronidase products do due to the advanced technology.

“HLB3-002 can be used for cosmetic procedures, dermatology, pain and edema treatment,” said Lim Chae-young, Huonslab's executive director of bio research. “It will also be valuable as a platform technology to convert intravenous medications into subcutaneous injections that can be self-administered.”

BY YOON SEUNG-JIN [yoon.seungjin@joongang.co.kr]