Alteogen Inc. has announced that the Ministry of Food and Drug Safety of Korea has granted approval for its New Drug Application for Tergase® (recombinant hyaluronidase). Developed using Alteogen's proprietary Hybrozyme™ Technology, Tergase® offers a highly purified form of recombinant human hyaluronidase. Initially designed for dermal filler removal, Tergase® also finds applications as a local anesthetic for eye surgeries and in orthopedic pain management. Unlike animal-derived hyaluronidases, which often have lower purity and higher immunogenicity, Tergase® boasts over 99% purity, making it suitable for a wider range of medical uses where animal-origin products may not be ideal.

The NDA approval was supported by a comprehensive Phase 1 clinical trial involving 244 healthy subjects, which confirmed its safety, tolerability, and pharmacokinetic characteristics. The primary endpoint of reducing allergic responses during intradermal administration was successfully met, with no incidence of anti-drug antibodies (ADA) observed, surpassing USFDA recommendations.

Alteogen, emphasized the approval as a significant milestone in the company's transition to a commercial-stage entity, aimed at advancing biologic treatments. With Tergase®'s superior safety profile and a projected global market value estimated at $1 billion, Alteogen anticipates expanding its partnerships for commercialization.

Tergase® (development code ALT-BB4) is derived from human hyaluronidase PH20, designed to enhance tissue permeability as an adjuvant for improving drug dispersion and absorption through subcutaneous or intradermal injection. Its formulation, free from human serum albumin, is presented as 1,500 IU/mL/vial, ensuring optimal efficacy and safety across various medical applications.

 

Source: prnewswire.com

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