Huonslab, a subsidiary of Huons Global, said Wednesday that it has received investigational new drug (IND) approval from the Ministry of Food and Drug Safety (MFDS) for a domestic phase 1 clinical trial of its recombinant human hyaluronidase, PH20 (rHuPH20), HLB3-002.

The trial will evaluate the safety and tolerability of a single subcutaneous injection of HLB3-002 in 243 healthy adults at four Korean medical institutions -- Seoul National University Hospital, Asan Medical Center, Konkuk University Medical Center, and Chung-Ang University Hospital.

Earlier, Huonslab conducted animal efficacy tests comparing HLB3-002 to Hylenex, a hyaluronidase injection from the U.S. biotech company, Halozyme Therapeutics. These tests confirmed that HLB3-002 demonstrated equivalent efficacy to Hylenex on multiple occasions. Non-clinical toxicology studies additionally established its safety.

Usually, phase 3 trials are pivotal but phase 1 trials can also be pivotal if they involve critical drugs or provide sufficient evidence for rare diseases.

For hyaluronidase, with existing animal-derived products like Hylenex that won approval based on phase 1 safety trials, a successful phase 1 trial for HLB3-002 could potentially lead directly to product approval without requiring additional phase 2 or 3 trials, a Huons official explained. 

If the study confirms the drug's safety and tolerability, Huonslab will file a formal request to market HLB3-002 through a Biologics License Application (BLA) with the MFDS by June next year.

Though similar in amino acid sequence to Hylenex and potentially a biosimilar, HLB3-002 is classified as a standalone product due to its proprietary design and technology, including unique glycan patterns and production processes, the Huonslab official said. “This distinction highlights its unique characteristics compared to biosimilars."

Existing animal-derived hyaluronidase products, which come from animal tissues like bovine or sheep, often carry contaminants and impurities from the extraction process, as revealed through purity and impurity tests. 

“In contrast, HLB3-002 is produced using genetic recombination in Chinese hamster ovary (CHO) cells, a widely accepted method in biopharmaceutical production,” the official said. “This process, which uses Huonslab’s patented manufacturing technology for HyDIFFUZETM, ensures high-purity human hyaluronidase without degradation products.

Huonslab secured domestic patent registration for the manufacturing method last July and is seeking international patent protection through the Patent Cooperation Treaty (PCT). The company expects HLB3-002 to cause fewer allergic reactions and side effects than animal-derived products.

“HLB3-002 has potential applications in cosmetic, dermatological, pain, and edema treatments,” said Im Chae-young, chief technology officer of Huonslab’s Bio Institute. “It could also be a platform technology for converting intravenous medications into self-administered subcutaneous injections.”