Overview
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).
About Tergase
- 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.
Phase 1 Clinical Trial
- 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.
Words from CEO: Alteogen
- 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).
