DAEJEON, South Korea, July 8, 2024 /PRNewswire/ -- Alteogen Inc. (KOSDAQ:196170) announced that the Ministry of Food and Drug Safety (MFDS) of Korea approved its New Drug Application (NDA) for Tergase® (recombinant hyaluronidase).
Tergase® is a recombinant human hyaluronidase developed utilizing Alteogen's proprietary Hybrozyme™ Technology. Dermal filler removal is the main product application, but it can also be used for various purposes, including local anesthetic solution for eye surgery, and orthopedics pain management. Mainly bovine or ovine-derived hyaluronidases with lower purity levels are available on the market, whereas owing to its recombinant source, Tergase® exhibits over 99% purity with lower immunogenicity. Given the superior product profile and comparative advantages, it is expected that the product applications will be extended to fields where animal-origin hyaluronidases have not been traditionally used.
The NDA submission is supported by a multicenter, 2-arm, randomized, double-blinded, placebo-controlled pivotal Phase 1 clinical trial involving 244 healthy subjects for the assessment of safety, tolerability, and pharmacokinetic characteristics. Primary endpoint - drug allergy response during intradermal administration – was met as the allergic response rate in the test group was significantly lower than the U.S. Food and Drug Administration (USFDA) recommendation as well as zero incidence of anti-drug antibodies (ADA) found.
MFDS approval of Tergase® marks a key milestone for Alteogen as it transitions to become a commercial-stage company and achieves its goal of delivering better biologics for patients.
"We are pleased to report this important milestone, and look forward to expanding our partnerships in commercializing Tergase®," said Dr. Soon Jae Park, Chief Executive Officer of Alteogen. "And having excellent safety profile compared to animal-derived hyaluronidase products on the market, Tergase® stands to emerge as a promising alternative in the global hyaluronidase market estimated to be around $1 billion in the near future."
About Tergase®
Tergase® (development code name ALT-BB4) is a stand-alone recombinant hyaluronidase derived from human hyaluronidase PH20, being investigated for a wide range of applications. Usage includes tissue permeability modifier indicated as an adjuvant to increase the dispersion and absorption of other injected drugs and topical anesthetics by subcutaneous or intradermal injection. Designed to achieve optimal balance between efficacy and safety, it is comprised of proprietary, human serum albumin-free liquid formulation with the presentation of 1,500 IU/mL/vial.
About Alteogen Inc.
Alteogen Inc. is a South Korea-based biopharmaceutical company that focuses on the development and commercialization of novel biologics such as Antibody-Drug Conjugates (ADCs), biobetters, and biosimilars. Alteogen's portfolio includes clinical-stage long-acting therapeutic proteins and next-generation ADCs, developed by its proprietary NexP™-fusion and NexMab™ platform technology, respectively. It also developed a proprietary recombinant human hyaluronidase enzyme utilizing Hybrozyme™ technology, which enables the large volume subcutaneous administration of drugs that are typically administered as an IV infusion. The company was founded in 2008 and listed in KOSDAQ (196170.KQ).
Contacts
US: Vivek Shenoy, Ph.D., MBA
Chief Business Officer
Phone: +18055708998
E-mail: vivek_shenoy@alteogen.com
ROW: Tae-Yon Chun, Ph.D., J.D.
Corporate Alliance Officer
Phone: +820428678861
E-mail: alliance@alteogen.com